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Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
Waste ManagementPlease refer to local legal requirements.
General Precautions1. Reagent, for professional in-vitrodiagnostic use only.
2. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
3. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 327 tests.
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 83 days.
Sample volume: 2 l/test
Detection limit:
The detection limit is determined according to the Valtec protocol (6)
and equals 2.9 mol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls aretested 20 times according to the recommendations found in the Valtec
protocol (6).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (7).
Linearity and Measuring Range:
The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (8).
Low linearity: 2.9 mol/l
High linearity: 909 mol/l, with automatic post-dilution: 1818 mol/l.
Correlation:
59 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (9).
The equation for the allometric line obtained is:
Y = 0.95 x + 22 with a correlation coefficient r = 0.992.
Interferences:
Conversion factora:
mol/l x 0.066 = g/l
mol/l x 0.0066 = g/dl
Calibration stabilityb:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 14 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 4.xx
WarningIt is the user's responsibility to verify that this document is applicable
to the reagent used.
Reference1. Doumas B. et al., Watson. W, Ard and Biggs H.G. Albumin
standards and the measurement of serum albmin with bromocresol
green, Clin. Chim. Acta, 31, (1971), 87.
2. Doumas B. T. and Biggs H.G., Determination of serum albumin
Standard Methods of Clinical Chemistry, Acad. Press N.Y., 7,
(1972), 175.
3. Drupt F., Dosage de lalbumine srique par le vert de bromocrsol
Pharm. Biol., 9, (1974), 777.4. Metais P. Biochimie Clinique. Tome 3: Biochimie fonctionnelle:
Srum Albumine. Paris: Simep; 1988:107.
5. Doumas BT., PETERS T Jr. - Serum and urine albumin albumin: a
progress report on their measurement and clinical significance.
Clin. Chim. Acta., 258(1), (1997), 3-20.
6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
7. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
Mean value mol/l CV %
Normal control 514 0.6
Pathological control 506 0.8
Specimen 1 349 0.4
Specimen 2 629 0.5
Specimen 3 848 0.8
Mean value mol/l CV %
Normal control 515 1.26
Pathological control 502 0.95
Specimen 1 357 1.66
Specimen 2 643 1.85
Haemoglobin: No significant influence is observed up to 232 mol/l
Triglycerides: No significant influence is observed up to 7 mmol/l
Total Bilirubin: No significant influence is observed up to 616 mol/l
Direct Bilirubin: No significant influence is observed up to 616 mol/l
a. Modification from index I to J: correction of conversion factor.b. Modification from index I to J: modification of calibration stability.
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Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
8. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
9. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
10. Johnson, A.M., Rohlfs, E.M., Silverman, L.M., Proteins, Tietz
Fundamentals of Clinical Chemistry, 5thEd., Burtis, C.A., Ashwood,
E.R., (W.B. Saunders eds. Philadelphia USA), (2001), 325.
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Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
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Bilirubin, Direct CP
ABX Pentra
2007/08/27A93A00122H EN
A11A01635
24 ml
7 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ABX Pentra Bilirubin, Direct CPRef.: A11A01635Volume R1: 24 mlVolume R2: 7 ml
Diagnostic reagent for quantitative in-vitrodetermination of direct Bilirubin in serumand plasma.
Clinical Interest (1,2)Bilirubin is a breakdown product of hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water, thus
forming a complex with albumin for the transport in the blood from
the spleen to the liver. In the liver, bilirubin is conjugated with
glucoronic acid and the resulting water soluble bilirubin glucoronicacid is excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin production due
to hemolysis (pre-hepatic jaundice), by parenchymal damages of the
liver (intra-hepatic jaundice) or by occlusion of bile ducts (post-hepatic
jaundice). A chronic congenital (predominantly unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in the
population. High levels of total bilirubin are observed in 60-70% of
neonates due to an increased postpartal breakdown of erythrocytes and
because of delayed function of enzymes for bilirubin degradation.
Common bilirubin methods detect either total bilirubin or direct
bilirubin. Determinations of direct bilirubin measure mainly conjugated,
water soluble bilirubin. Unconjugated bilirubin can therefore be
estimated as the difference between total bilirubin and direct bilirubin.
MethodPhotometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a
red colored azocompound in acidic solution.
ReagentsABX Pentra Bilirubin, Direct CPis ready-to-use.
ABX Pentra Bilirubin, Direct CP should be used according to thisreagent notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
Handlinga
Remove both caps of the cassette. If present, remove foam by using a
plastic pipette.
Position the respective protective cap, ref. GBM0969 on R1 and Ref.
GBM0970 on R2 and place in the refrigerated ABX Pentra 400 reagent
compartment.
Reagent 1: EDTA-Na2 0.1 mmol/l
NaCl 9 g/l
Sulfamic acid 100 mmol/l
Reagent 2: 2,4-Dichlorophenyl-diazonium salt 0.5 mmol/l
HCl 700 mmol/l
EDTA-Na2 0.13 mmol/l
a. Modification from index G to H: new handling.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml (lyophilisate)
Control
For internal quality control, use:ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided
Automated clinical chemistry analyser NaCl solution: 9 g/l
Standard laboratory equipment.
Specimen Serum.
Heparin Plasma.
It is very important to store the sample protected from light.
Freeze only once.
Stability: 2 days at 15 - 25 C
7 days at 2 - 8 C
3 months at - 20 C in case of immediate freezing.
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Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Reference range (1)Adults and children:0 - 0.2 mg/dl (0 - 3.4 mol/l).
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2 - 8 C protected from light and contamination
is avoided.
Stability after opening : refer to the paragraph Performance on ABX
Pentra 400.
Do not freeze the reagents.
Assay Procedure
Test instructions for other automated systems than ABX Pentra 400 areavailable on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory reagents.
3. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 100 tests
On board Reagent Stabilitya:Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 30 days.
Sample volume: 25 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (4)
and equals 0.69 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (4).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (5).
Linearity and Measuring Range:The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (6).Low linearity: 0.69 mol/l
High linearity: 116 mol/l, with automatic post-dilution: 580 mol/l.
Correlation:100 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (7).
The equation for the allometric line obtained is:
Y = 0.92 x + 0.58 with a correlation coefficient r2= 0.9899.
Interferences:
Conversion factor:mol/l x 0.584 = mg/l
mol/l x 0.0584 = mg/dl
Calibration stabilityb:The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 10 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release
c
: 3.xx
WarningIt is the users responsibility to verify that this document is applicable
to the reagent used.
Reference1. Thomas L. ed. Clinical Laboratory Diagnostics. 1sted. Frankfurt:
TH-Books Verlagsgesellschaft, 1998; 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rded. Philadelphia:
W.B Saunders Company; 1999. p. 1125-1177.
a. Modification from index G to H: new on board reagent stability.
Mean value mol/l CV %
Normal control 15.3 0.67
Pathological control 31.6 0.44
Specimen 1 4.0 3.23
Specimen 2 25.9 0.59
Specimen 3 134.6 2.69
Mean value mol/l CV %
Normal control 16.0 4.26
Pathological control 34.6 4.22
Specimen 1 11.7 3.27
Specimen 2 65.4 2.98
Haemoglobin: Do not use haemolysed samples.
Triglycerides: No significant influence is observed up to 7 mmol/l.
b. Modification from index G to H: modification of calibration stability.c. Modification from index F to G: suppression of minor index.
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Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
3. Rand R.N., di Pasqua A. A new diazo method for the determination
of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.5. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
7. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
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Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
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Bilirubin, Total CP
ABX Pentra
2009/10/21A93A00112O EN
A11A01639
44 ml
14 ml
HORIBA ABX SAS
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
ABX Pentra Bilirubin, Total CPRef.: A11A01639Volume R1: 44 mlVolume R2: 14 ml
Intended Use
Diagnostic reagent for quantitative in-vitrodetermination of total Bilirubin in serum and plasmaof adults and neonates.
Clinical Interest (1,2)Bilirubin is a breakdown product of hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water, thus
forming a complex with albumin for the transport in the blood from
the spleen to the liver. In the liver, bilirubin is conjugated with
glucoronic acid and the resulting water soluble bilirubin glucoronidesare excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin production
due to hemolysis (pre-hepatic jaundice), by parenchymal damages of
the liver (intra-hepatic jaundice) or by occlusion of bile ducts (post-
hepatic jaundice). A chronic congenital (predominantly unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in the
population. High levels of total bilirubin are observed in 60-70% of
neonates due to an increased postpartal breakdown of erythrocytes
and because of delayed function of enzymes for bilirubin degradation.
Common bilirubin methods detect either total bilirubin or direct
bilirubin. Determinations of direct bilirubin measure mainly
conjugated, water soluble bilirubin. Unconjugated bilirubin can
therefore be estimated as the difference between total bilirubin and
direct bilirubin.
Method (3)Photometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a
red colored azocompound in acidic solution. A specific mixture of
detergents enables a safe determination of the total bilirubin.
ReagentsABX Pentra Bilirubin, Total CPis ready-to-use.
ABX Pentra Bilirubin, Total CP should be used according to thisreagent notice. The manufacturer cannot guarantee its performance if
used otherwise.
HandlingRemove both caps of the cassette, place in the refrigerated ABX Pentra
400 reagent compartment.
If present, remove foam by using a plastic pipette.
Reagent 1:Phosphate buffer 50 mmol/l
NaCl 9 g/l
Detergent, stabilizersReagent 2:2,4-Dichlorophenyl-diazonium salt 5 mmol/l
HCl 130 mmol/l
Detergent
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml (lyophilisate)
Control
For internal quality control, use:ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry analyser: ABX PENTRA 400 Calibrator: ABX Pentra Multical, Ref. A11A01652 Controls: ABX Pentra N Control, Ref. A11A01653, and
ABX Pentra P Control, Ref. A11A01654 NaCl solution 9 g/l
Standard laboratory equipment.
Specimen Serum.
Plasma in lithium heparin.
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Bilirubin, Total CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
Stability (1,10):
1 day at 20-25C
7 days at 4-8C
6 months at -20C
It is very important to store the sample protected from light!
In the case of intensive sun irradiation: decrease in total bilirubin by
up to 30% after 1 hour.
Reference range (1)Each laboratory should establish its own reference ranges. The values
given here are used as guidelines only.
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2 - 8 C and contamination is avoided.
Stability after opening : refer to the paragraph Performance on ABX
Pentra 400.Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are
available on request (not available in the USA).
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory reagents.
3. The reagent cassettes are disposable and should be disposed of inaccordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 200 tests
On board Reagent Stability:Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 25 days.
Sample volume: 8 l/test
Limits:Limit of blank:
The limit of blank is determined according to CLSI (NCCLS), EP17-A
protocol (8) and equals 1.09 mol/l.
Limit of detection:
The detection limit is determined according to CLSI (NCCLS), EP17-A
protocol (8)and equals 1.49 mol/l.
Limit of quantitation:The limit of quantitation is determined according to CLSI (NCCLS),
EP17-A protocol (8) and equals 2.4 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
4 specimens of very low, low, medium and high concentration and 2
controls are tested 20 times according to the recommendations found
in the Valtec protocol (4).
Reproducibility (total precision)
3 specimens of low, medium and high levels and 2 controls are tested
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol (5).
Measuring Range:The assay confirmed a measuring range in serum and plasma from 2.4
to 450.0 mol/l, providing an upper linearity of 450.0 mol/l, with an
automatic post-dilution up to 1350 mol/l.
The reagent linearity is determined according to the recommendations
found in the CLSI (NCCLS), EP6-A protocol (6)
Correlation (adult samples):101 patient samples (serum)are correlated with a commercial reagent
taken as reference according to the recommendations found in the
CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 5.6 to 441.8
mol/l.
mg/dl mol/l
Neonates:
24 hours: < 8.7 < 150
2nd day: 1.3 - 11.3 22 - 193
3rd day: 0.7 - 12.7 12 - 217
4th - 6th day: 0.1 - 12.6 2 - 216
Adults: 0.1 - 1.2 2 - 21
Mean value mol/l CV %
Control specimen 1 16.59 2.14
Control specimen 2 87.61 0.99
Specimen 1 10.34 3.09
Specimen 2 14.57 2.23Specimen 3 37.65 1.33
Specimen 4 142.82 0.83
Mean value mol/l CV %
Control specimen 1 17 4.04
Control specimen 2 94 1.70
Specimen 1 13.62 5.97
Specimen 2 48.96 2.78Specimen 3 156.13 2.20
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Bilirubin, Total CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com
The equation for the allometric line obtained using Passing-Bablock
regression procedure (9)is:
Y = 1.03 x - 2.43 mol/l with a correlation coefficient r2= 0.9965.
Correlation (neonatal samples):112 patient samples (serum) are correlated with a commercial reagent
taken as reference according to the recommendations found in the
CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 3.17 to 434.14
mol/l.
The equation for the allometric line obtained using Passing-Bablock
regression procedure (9) is:
Y = 0.95 X + 0.085 mol/l with a correlation coefficient r2= 0.993.
Interferences:
Other limitations are given by Young as a list of drugs and preanalytical
variables known to affect this methodology (11,12).
Calibration stability:The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 10 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Conversion factor:mol/l x 0.585 = mg/l
mol/l x 0.0585 = mg/dl
Software version: 4.4 - Application release: 7.xx
Software version: 5.0 - Application release: 8.xx
Warning
It is the users responsibility to verify that this document is applicableto the reagent used.
Reference1. Thomas L. ed. Clinical Laboratory Diagnostics. 1sted. Frankfurt:
TH-Books Verlagsgesellschaft, 1998. p 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rded. Philadelphia:
W.B Saunders Company; 1999. p. 1125-77.
3. Rand R.N., di Pasqua A. A new diazo method for the determination
of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.5. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
7. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.
8. Protocols for determination of limits of detection and limits of
quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,
Vol. 24, No. 34, 2004.
9. Passing H., Bablock W. A new biometrical procedure for testing the
equality of measurements from two different analytical methods.
J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.
10. Use of Anticoagulants in Diagnostics Laboratory Investigations.
WHO Publication WHO/DIL/LAB/99.1 rev.2, 2002.
11. Young D.S., Effects of Drugs on Clinical Laboratory Tests, 4th
Edition, Washington, DC, AACC Press, 1995, 3: 143-163.
12. Young D.S., Effects of Preanalytical Variables on Clinical
Laboratory Tests, 2ndEdition, Washington, DC, AACC Press, 1997,
3: 120-132.
Haemoglobin: No significant influence is observed up to 500 mg/dl
(290 mol/l).
Triglycerides: No significant influence is observed up to 612.5 mg/dl
(7 mmol/l).
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Calcium AZ III CP
ABX Pentra
2008/09/09A93A01221A EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
A11A01894
79 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Calcium AZ III CPRef.: A11A01894Volume R1: 79 mlVolume R2: 1 x 5 ml
Intended use
Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasma andurine.
Clinical Interest (1,2,3)Calcium plays an essential role in many cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly, in
bone mineralization, in blood coagulation and in transmission of nerve
impulses. Calcium is present in plasma in three forms: free, bound to
proteins or complexed with anions as phosphate, citrate andbicarbonate. Under physiological conditions, calcium balance is
determined by the relationship between calcium intake and calcium
absorption and excretion. Urinary excretion is an important
determinant of calcium retention in the body.
Decreased total calcium levels can be associated with diseases of the
bone apparatus (especially osteoporosis), kidney diseases (especially
under dialysis), defective intestinal absorption and
hypoparathyroidism.
Increased total calcium can be measured in hyperparathyroidism,
malignant diseases with metastases and sarcoidosis. Calcium
measurements also help in monitoring of calcium supplementation
mainly in the prevention of osteoporosis.
Method (4,5,6,7)Many colourimetric methods for determining calcium have been used
in the past. Connerty and Briggs described methods using alizarin 3-
sulphonate (4)and cresolphthalein complexone (5)whilst Gindler and
King have described a method using thymol blue (6).
There have been many subsequent modifications to these methods.
The method used here is based on the metallochromogen Arsenazo III.
Calcium ions (Ca2+) react with Arsenazo III (2,2-[1,8-Dihydroxy-3,6-
disulphonaphthylene-2,7-bisazo]- bisbenzenearsonic acid) at pH 6.75
to form an intense purple coloured chromophore. The absorbance of
the Ca-Arsenazo III complex is measured bichromaticcally at 660/700
nm. The resulting increase in absorbance of the reaction mixture is
directly proportional to the calcium concentration in the sample.
Arsenazo III has a high affinity (K = 1 x 10-7) for calcium ions (7) andshows no interference from other cations normally present in serum,
plasma or urine.
pH 6.75Ca+++ Arsenazo III Ca-Arsenazo III complex (purple)
ReagentsABX Pentra Calcium AZ III CPis ready-to-use.
ABX Pentra Calcium AZ III CP should be used according to this
reagent notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingRemove the cap of the cassette. If present, remove foam by using a
plastic pipette. Position the protective cap, ref. GBM0969 and place
the cassette in the refrigerated ABX Pentra 400 reagent compartment.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)
1 x 10 ml + 1 x 10 ml
Reagent : Arsenazo III 0.2 mmol/l
Imidazole buffer 100 mmol/l
Sodium azide 0.05%
SurfactantStabilizers
pH 6.75 0.1
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Calcium AZ III CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (11).
Reproducibility (total precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the CLSI
(NCCLS) EP05-A protocol (12).
Measuring Range:
The assay confirmed a measuring range from 0.1 mmol/l to 4.50 mmol/l, providing an upper linearity of 4.50 mmol/l, with an automatic post-
dilution up to 13.50 mmol/l.
The reagent linearity is determined according to the recommendations
found in the CLSI (NCCLS), EP6-A protocol (13).
Correlation:
134 patient samples (serum) are correlated with a commercial reagent
taken as reference according to the recommendations found in the
CLSI (NCCLS), EP9-A2 protocol (14). Values ranged from 0.16 to 4.40
mmol/l.
The equation for the allometric line obtained using Passing-Bablock
regression procedure (15)is:
Y = 0.98 x - 0.02 with a correlation coefficient r2= 0.9958.
Interferences:
Other limitations are given by Young as a list of drugs and preanalytical
variables known to affect this methodology (16,17).
Conversion factor:
mmol/l x 40.1 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 7 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 2.xx
Urine
Number of tests: 250 tests
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 60 days.
Sample volume: 6 l/test
Detection limit:The detection limit is determined according to CLSI (NCCLS), EP17-A
protocol (10)and equals 0.08 mmol/l.
Limit of quantitation:
The limit of quantitation is determined according to CLSI (NCCLS),
EP17-A protocol (10)and equals 0.25 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (11).
Mean value mmol/l CV %
Control specimen 1 2.30 0.46
Control specimen 2 2.89 0.51
Specimen 1 1.80 0.93
Specimen 2 2.42 0.70
Specimen 3 3.32 0.73
Mean value mmol/l CV %
Control specimen 1 2.33 2.53
Control specimen 2 2.94 2.29
Specimen 1 1.84 1.75
Specimen 2 2.48 2.30
Specimen 3 3.40 1.78
Haemoglobin: No significant influence is observed up to 290 mol/l
(500 mg/dl).
Triglycerides: No significant influence is observed up to 7 mmol/l
(612.5 mg/dl).
(as Intralipid, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 400 mol/l
(23.4 mg/dl).
Direct Bilirubin:No significant influence is observed up to 450 mol/l
(26.3 mg/dl).
Mean value mmol/l CV %
Control specimen 1 1.73 1.14
Control specimen 2 2.55 0.71
Specimen 1 1.02 0.92
Specimen 2 2.49 0.74
Specimen 3 4.03 0.52
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Calcium AZ III CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Reproducibility (total precision)
3 specimens of low, medium and high levels and 2 controls are tested
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol (12).
Measuring Range:
The assay confirmed a measuring range from 0.25 mmol/l to 4.50mmol/l, with an automatic post-dilution up to 13.50 mmol/l.
The reagent linearity has been assessed up to 4.50 mmol/l, in
accordance with CLSI (NCCLS), EP6-A protocol (13).
Correlation:
83 patient samples (urine) are correlated with a commercial reagent
taken as reference according to the recommendations found in the
CLSI (NCCLS), EP9-A2 protocol (14). Values ranged from 0.27 to 4.40
mmol/l.
The equation for the allometric line obtained using Passing-Bablock
regression procedure (15)is:
Y = 0.90 x - 0.01 with a correlation coefficient r2= 0.9885.
Interferences:
Other limitations are given by Young as a list of drugs and preanalytical
variables known to affect this methodology (16,17).
Conversion factor:mmol/l x 40.1 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 7 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 2.xx
WarningIt is the users responsibility to verify that this document is applicable
to the reagent used.
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted. Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.
3. Matkovic V., Llich J.Z.; Andon M.B.; Hsieh L.C., Tzagournis M.A.,
Lagger B.J.; Goel PK., Am. J. Clin. Nutr., 1995, 62(2):417-25.
4. Connerty HV, Briggs AR.: Clin. Chem., 1965; 11: 716-28..5. Connerty HV, Briggs AR.: Am. J. Clin. Path., 1966; 45: 290-6.
6. Gindler EM, Kin JD, Am.: J. Clin. Path., 1972; 58: 376-82.
7. Bauer PJ Anal.: Biochem, 1981; 110: 61-72.
8. NCCLS. Urinalysis and collection, transportation and preservation
of urine specimen; Approved guideline - 2nd Edition, NCCLS
document GP16-A2, Vol.21, No 19.
9. Use of anticoagulants in diagnostic laboratory investigations. WHO
publication WHO/DIL/LAB/99.1 Rev.2, 2002.
10. Protocols for determination of limits of detection and limits of
quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,
Vol. 24, No. 34, 2004.
11. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
12. Evaluation of Precision Performance of Clinical Chemistry Devices,Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,
february 1999.
13. Evaluation of the Linearity of Quantitative Analytical Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
14. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.
15. Passing H., Bablock W. A new biometrical procedure for testing the
equality of measurements from two different analytical methods.
J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.
16. Young D.S., Effects of Preanalytical Variables on Clinical
Laboratory Tests, 2nd
Edition, Washington, DC, AACC Press, 1997,3: 120-132.
17. Young D.S., Effects of Drugs on Clinical Laboratory Tests, 4th
Edition, Washington, DC, AACC Press, 1995, 3: 143-163.
Mean value mmol/l CV %
Control specimen 1 1.75 2.27
Control specimen 2 2.55 1.82
Specimen 1 1.18 6.58
Specimen 2 2.71 2.10
Specimen 3 4.40 1.98
Haemoglobin: No significant influence is observed up to 290 mol/l
(500 mg/dl).
Triglycerides: No significant influence is observed up to 7 mmol/l
(612.5 mg/dl).
(as Intralipid, representative of lipemia)
Direct Bilirubin:No significant influence is observed up to 438 mol/l
(25.6 mg/dl).
Acidification No significant influence is observed up to pH 2.
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Calcium CP
ABX Pentra
2007/09/06A93A00132N EN
A11A01633
66 ml
16.5 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ABX Pentra Calcium CPRef.: A11A01633Volume R1: 66 mlVolume R2: 16.5 ml
Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasmaor urine.
Clinical Interest (1,2)Calcium plays an essential role in many cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly, in
bone mineralization, in blood coagulation and in transmission of nerve
impulses. Calcium is present in plasma in three forms: free, bound to
proteins or complexed with anions as phosphate, citrate andbicarbonate. Decreased total calcium levels can be associated with
diseases of the bone apparatus (especially osteoporosis), kidney
diseases (especially under dialysis), defective intestinal absorption
and hypoparathyroidism. Increased total calcium can be measured in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of calcium
supplementation mainly in the prevention of osteoporosis.
MethodPhotometric test using ortho-cresolphtalein complexone (OPC).
Cresolphthalein complexone reacts with calcium ions in alkaline
medium forming a red-violet color. Interference by magnesium is
eliminated by addition of 8-hydroxyquinoline.
ReagentsABX Pentra Calcium CPis ready-to-use.
ABX Pentra Calcium CP should be used according to this reagentnotice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingRemove both caps of the cassette. If present, remove foam by using a
plastic pipette. Position the respective protective cap, ref. GBM0969
on R1 and Ref. GBM0970 on R2 and place in the refrigerated ABX
Pentra 400 reagent compartment.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml (lyophilisate)
Reagent 1: Ethanolamine pH 10.7 0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline 34.5 mmol/l
Hydrochloric acid pH 1.1 100 mmol/l
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x 10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry analyser
Standard laboratory equipment.
Specimen Serum. heparin Plasma.
Urine.
Do not use EDTA plasma.
Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to
dissolve calcium oxalate.
Stability in: Serum /Plasma: 7 days at 20 - 25 C
3 weeks at 4 - 8 C
8 months at - 20 C
Urine: 2 days at 20 - 25 C
4 days at 4 - 8 C
3 weeks at - 20 C
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Reference range (2)
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2-8C, protected from light, and contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of CO2absorption from the air.
Stability after opening: refer to the paragraph Performance on ABX
Pentra 400.
Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional in-vitrodiagnostic use only.
2. As calcium is an ubiquitous ion, essential precaution must be taken
against accidental contamination. Only use disposable materials.
3. Take the necessary precautions for the use of laboratory reagents.
4. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
5. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 250 tests
On board Reagent Stability:Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 31 days.
Sample volume: 4 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (5)
and equals 0.04 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (5).
Reproducibility (run-to-run precision)
A variance analysis is carried out for 6 days out of 2 specimens of low
and high levels and 2 controls.
Linearity and Measuring Range:The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.04 mmol/l
High linearity: 5 mmol/l
Correlation:100 patient samples are correlated with another method taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (8).The equation for the allometric line obtained is:
Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907 .
Interferences:
Conversion factor:mmol/l x 40 = mg/l
Calibration stabilitya
:The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 1 day.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 5.xx
Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women:
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Urine
Number of tests: 250 tests
On board Reagent Stability:Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 31 days.
Sample volume: 4 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (5)
and equals 0.03 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (5).
Reproducibility (run-to-run precision)2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (6).
Linearity and Measuring Range:The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.03 mmol/l.High linearity: 6 mmol/l.
Correlation:100 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x - 0.09 with a correlation coefficient r2= 0.98.
Interferences:
Conversion factor:mmol/l x 40 = mg/l
Calibration stabilitya:The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 1 day.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 7.xx
WarningIt is the users responsibility to verify that this document is applicable
to the reagent used.
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted. Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining microquantities of calcium in biological materials. Anal. Biochem. 1967;
20:155-166.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.6. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
8. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
Mean value mmol/l CV %
Normal control 1.69 0.71
Pathological control 3.15 0.70
Specimen 1 1.09 0.64
Specimen 2 2.96 0.44
Specimen 3 7.22 1.37
Mean value mmol/l CV %
Normal control 1.64 2.44
Pathological control 3.11 2.21
Specimen 1 1.45 3.15
Specimen 2 6.20 2.91
Haemoglobin: No significant influence is observed up to 55 mol/l.
a.Modification from index M to N: Modification of calibration stability.
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
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Calcium CP
ABX Pentra
Use in reagent rack
2008/04/21A93A01182G EN
A11A01633
66 ml
16.5 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ABX Pentra Calcium CP (Rack)Use in reagent rackRef. : A11A01633Volume R1: 66 mlVolume R2: 16.5 ml
Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasmaor urine.
Clinical Interest (1,2)Calcium plays an essential role in many cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly, in
bone mineralization, in blood coagulation and in transmission of nerve
impulses. Calcium is present in plasma in three forms: free, bound to
proteins or complexed with anions as phosphate, citrate andbicarbonate. Decreased total calcium levels can be associated with
diseases of the bone apparatus (especially osteoporosis), kidney
diseases (especially under dialysis), defective intestinal absorption
and hypoparathyroidism. Increased total calcium can be measured in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of calcium
supplementation mainly in the prevention of osteoporosis.
MethodPhotometric test using ortho-cresolphtalein complexone (OPC).
Cresolphthalein complexone reacts with calcium ions in alkaline
medium forming a red-violet color. Interference by magnesium is
eliminated by addition of 8-hydroxyquinoline.
ReagentsABX Pentra Calcium CPis ready-to-use.
ABX Pentra Calcium CP should be used according to this reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingTransfer the required volume of Reagent 1in a container 15, 10 or 4 ml.
Transfer the required volume of Reagent 2in a container 10 or 4 ml.
Reagent 1 and Reagent 2 should be placed on the same reagent rack
sector A, B or C (see diagram below, sector A is taken as an example).
Reagent 1: Ethanolamine pH 10.7 0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline 34.5 mmol/l
Hydrochloric acid pH 1.1 100 mmol/l
Place Reagent 1in position 1 of one available sector using either:
Reagent container 15 ml
Reagent container 10 ml + its specific adaptor
Reagent container 4 ml + its specific adaptor
Place Reagent 2in position 2 of same selected sector using either:
Reagent container 10 ml
Reagent container 4 ml + its specific adaptor
Place the reagent rack in the refrigerated ABX Pentra 400 reagent
compartment.
Important : Discard the remaining reagent at the end of the day.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
ABX Pentra Calcium CPReagent 2
ABX Pentra Calcium CP
Reagent 1
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)
1 x 10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry analyser
Standard laboratory equipment.
Specimen Serum.
heparin Plasma.
Urine.
Do not use EDTA plasma.
Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to
dissolve calcium oxalate.
Reference range (2)
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2-8C, protected from light, and contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of CO2absorption from the air.
Stability after opening: 28 days if the reagents are stored in a capped
cassette between 2 and 8C.
Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional in-vitrodiagnostic use only.
2. As calcium is an ubiquitous ion, essential precaution must be
taken against accidental contamination. Only use disposable
materials.
3. Take the necessary precautions for the use of laboratory reagents.4. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
5. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 250 tests
Sample volume: 4 l/test
Detection limit:
The detection limit is determined according to the Valtec protocol (5)
and equals 0.04 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (5).
Reproducibility (run-to-run precision)
A variance analysis is carried out for 6 days out of 2 specimens of low
and high levels and 2 controls.
Stability in: Serum /Plasma: 7 days at 20 - 25 C3 weeks at 4 - 8 C
8 months at - 20 C
Urine: 2 days at 20 - 25 C
4 days at 4 - 8 C
3 weeks at - 20 C
Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women:
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Linearity and Measuring Range:
The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.04 mmol/l
High linearity: 5 mmol/l
Correlation:
100 patient samples are correlated with another method taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907 .
Interferences:
Conversion factor:
mmol/l x 40 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 4 hours.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application releasea: 3.xx
Urine
Number of tests: 250 tests
Sample volume: 4 l/test
Detection limit:
The detection limit is determined according to the Valtec protocol (5)and equals 0.03 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (5).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (6).
Linearity and Measuring Range:
The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.03 mmol/l.
High linearity: 6 mmol/l.
Correlation:
100 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x - 0.09 with a correlation coefficient r2= 0.98.
Interferences:
Conversion factor:
mmol/l x 40 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is 4 hours.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application releaseb: 3.xx
WarningIt is the users responsibility to verify that this document is applicable
to the reagent used.
Haemoglobin: No significant influence is observed up to 195 mol/l.
Triglycerides: No significant influence is observed up to 7 mmol/l.
Total Bilirubin: No significant influence is observed up to 101 mol/l.
Direct Bilirubin: No significant influence is observed up to 1357 mol/l
a. Modification from index F to G: suppression of minor index.
Mean value mmol/l CV %
Normal control 1.69 0.71
Pathological control 3.15 0.70
Specimen 1 1.09 0.64
Specimen 2 2.96 0.44
Specimen 3 7.22 1.37
Mean value mmol/l CV %Normal control 1.64 2.44
Pathological control 3.11 2.21
Specimen 1 1.45 3.15
Specimen 2 6.20 2.91
Haemoglobin: No significant influence is observed up to 55 mol/l.
b. Modification from index F to G: suppression of minor index.
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted. Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:
46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining micro
quantities of calcium in biological materials. Anal. Biochem. 1967;
20:155-166.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
6. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
8. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
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Cholesterol CP
ABX Pentra
2008/11/17A93A00142K EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
A11A01634
90 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Cholesterol CPRef.: A11A01634Volume: 90 ml
Diagnostic reagent for quantitative in-vitrodetermination of Cholesterol in serum or plasma.
Clinical InterestCholesterol is a component of cell membranes and a precursor for
steroid hormones and bile acids synthesized by body cells and
absorbed with food (1). Cholesterol is transported in plasma via
lipoproteins, namely complexes between lipids and apolipoproteins
(1). There are four classes of lipoproteins: high density lipoproteins(HDL), low density lipoproteins (LDL), very low density lipoproteins
(VLDL) and chylomicrons. While LDL is involved in the cholesterol
transport to the peripheral cells, HDL is responsible for the cholesterol
uptake from the cells. The four different lipoprotein classes show
distinct relationship to coronary atherosclerosis (1). LDL-cholesterol
(LDL-C) contributes to atherosclerotic plaque formation within the
arterial intima and is strongly associated with coronary heart disease
(CHD) and related mortality. Even with total cholesterol within the
normal range an increased concentration of LDL-C indicates high risk.
HDL-C has a protective effect impeding plaque formation and shows an
inverse relationship to CHD prevalence. In fact, low HDL-C values
constitute an independent risk factor. The determination of the
individual total cholesterol (TC) level is used for screening purposes
while for a better risk assessment it is necessary to measure
additionally HDL-C and LDL-C.
In the last few years several controlled clinical trials using diet, life
style changes and / or different drugs (especially HMG CoA reductase
inhibitors [statins]) have demonstrated that lowering total cholesterol
and LDL-C levels reduce drastically CHD risk (2).
MethodCHOD-PAP: enzymatic photometric test.
Determination of cholesterol after enzymatic hydrolysis and oxidation
(3,4). The colorimetric indicator is quinoneimine which is generated
from 4-aminoantipyrine and phenol by hydrogen peroxide under the
catalytic action of peroxidase (Trinders reaction) (3).
(CHE = Cholesterol Esterase, CHO = Cholesterol oxydase, POD = Peroxidase)
Cholesterol ester + H2O Cholesterol + Fatty acidCHE
Cholesterol + O2 Cholesterol-3-one + H2O2CHO
2H2O2+ 4-Aminoantipyrine + Phenol Quinoneime + 4H2OPOD
ReagentsABX Pentra Cholesterol CPis ready-to-use.
ABX Pentra Cholesterol CPshould be used according to this reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingRemove the cap of the cassette, place in the refrigerated ABX Pentra
400 reagent compartment.
If present, remove foam by using a plastic pipette.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
Reagent: Goods buffer pH 6.7 50 mmol/l
Phenol 5 mmol/l
4-Aminoantipyrine 0.3 mmol/l
Cholesterol esterase (CHE) 200 U/lCholesterol oxidase (CHO) 50 U/l
Peroxidase (POD) 3 kU/l
Sodium azide 0.95 g/l
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry analyser
Standard laboratory equipment.
Specimen Serum.
Heparin Plasma or EDTA Plasma.
Reference range (5)
The European Task Force on Coronary Prevention recommends to lower
TC concentration to less than 190 mg/dl (5.0 mmol/l) and LDL-
cholesterol to less than 115 mg/dl (3.0 mmol/l) (2).
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2-8C, protected from light and contamination is
avoided.
Stability after opening : refer to the paragraph Performance on ABX
Pentra 400.
Do not freeze the reagents.
Note: It has to be mentioned, that the measurement is not influenced
by occasionally occurring color changes, as long as the absorbance of
the reagent is 240 mg/dl (>6.2 mmol/l)
Mean value mmol/l CV %
Normal control 2.92 0.82
Pathological control 4.81 0.74
Specimen 1 3.03 1.21
Specimen 2 4.93 0.53
Specimen 3 10.04 0.62
Mean value mmol/l CV %
Normal control 2.83 2.96
Pathological control 4.74 2.34
Specimen 1 4.40 2.80
Specimen 2 6.45 3.01
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Linearity and Measuring Range:
The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (8).
Low linearity: 0.09 mmol/l.
High linearity: 15 mmol/l.
Correlation:
102 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (9).
The equation for the allometric line obtained is:
Y = 1.00 x - 0.4 with a correlation coefficient r2= 0.97.
Interferences:
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 8 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Conversion factor:
mmol/l x 0.387 = g/l
mmol/l x 38.7 = mg/dl
Application releasea: 6.xx
WarningIt is the users responsibility to verify that this document is applicable
to the reagent used.
Reference1. Rifai N., Bachorik P.S., Albers J.J. Lipids, lipoproteins and
apolipoproteins. In: Burtis C.A., Ashwood E.R., editors. Tietz
Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B. Saunders
Company; 1999. p. 809-861.
2. Recommendation of the Second Joint Task Force of European and
other Societies on Coronary Prevention. Prevention of coronary
heart disease in clinical practice. Eur. Heart J. 1998; 19, 1434-
1503.
3. Artiss J.D., Zak B. Measurement of cholesterol concentration. In:
Rifai N., Warnick G.R., Dominiczak M.H., eds. Handbook of
lipoprotein testing. Washington: AACC Press, 1997, 99-114.
4. Deeg R., Ziegenhorn J. Kinetic enzymatic method for automated
determination of total cholesterol in serum. Clin. Chem. 1983; 29,
1798-1802.
5. Schaefer E.J., McNamara J. Overview of the diagnosis and
treatment of lipid disorders. In: Rifai N., Warnick G.R., Dominiczak
M.H., eds. Handbook of lipoprotein testing. Washington: AACC
press, 1997, 25-48.
6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
7. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
8. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
9. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.Haemoglobin: No significant influence is observed up to 195 mol/l
Triglycerides: No significant influence is observed up to 7 mmol/l
Total Bilirubin: No significant influence is observed up to 350 mol/l
Direct Bilirubin: No significant influence is observed up to 117 mol/l
a. Modification from index J to K: new application release.
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
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CO2RTU
ABX Pentra
2007/07/05A93A00172I EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
A11A01645
2 x 20 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra CO2RTURef.: A11A01645Volume: 2 x 20 ml
Diagnostic reagent for quantitative in-vitrodetermination of Bicarbonate / total CO2in serum or plasma.
Clinical Interest (1)Plasmatic bicarbonates are one of the principle buffer of the organism.
Their measurement is used in the diagnosis of the acid-base-balance
in the blood. This balance is based on the Henderson-Hasselbach
equation (pH=pK+log[bicarbonates/apCO2]) which implies that all
compensation mechanisms are intended for maintening the relation(bicarbonates/apCO2) constant.
Elevated and decreased values indicate disorders associated with
disturbances of the metabolic and respiratory systems.
MethodEnzymatic test using phosphoenolpyruvate carboxylase (PEPC) and a
stable NADH analog.
The reaction disturbs following equilibrium:
(PEPC = Phosphoenolpyruvate carbolyxase, MDH = Malate Dehydrogenase)
This results in a conversion of CO2to bicarbonate (HCO3-) which then
is included in the reaction. Therefore the total CO2concentration is
measured.
The decrease of reduced cofactor concentration is measured at 405 nm
and is proportional to the concentration of total carbon dioxide in the
sample.
Reagents
ABX Pentra CO2RTUis ready-to-use.
ABX Pentra CO2RTUshould be used according to this reagent notice.HORIBA ABX cannot guarantee its performance if used otherwise.
Reagent: Buffer pH 7.5
Phosphoenolpyruvate (PEP) 12.5 mmol/l
Phosphoenolpyruvate carboxylase (PEPC) >400 U/l
Malate dehydrogenase (MDH) >4100 U/l
NADH analog 0.6 mmol/l
Activators, stabilizers, surfactant, preservative
Phosphoenolpyruvate + HCO3- Oxaloacetate + H2PO4
-PEPC + Mg2+
Oxaloacetate + Cofactor red. Malate + CofactorMDH
CO2+ H2O H+ + HCO3
-H2CO3
HandlingTransfer the necessary Reagent 1volume for one day of tests into areagent container 15, 10 or 4 ml.
Place Reagent 1in position 1 of one available sector using either: Reagent container 15 ml
Reagent container 10 ml + its specific adaptor
Reagent container 4 ml + its specific adaptor
Place the reagent rack in the refrigerated ABX Pentra 400 reagent
compartment. Wait for 3 hours to stabilize the reagent.
Important: Discard the remaining reagent at the end of the day.
CalibratorFor calibration, use:
ABX Pentra CO2Cal, Ref. A11A01648 (not included)3 x 3 ml
ABX Pentra CO2 RTUReagent 1
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra CO2Control, Ref. A11A01650 (not included)3 x 3 ml
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided
Automated clinical chemistry analyser Standard laboratory equipment.
Specimen Serum.
heparin Plasma.
1. Serum or plasma should be separated from cells immediately.
2. Exposure of samples to air should be minimized.
3. Samples should be stored tightly sealed to prevent loss of carbon
dioxide and assayed as soon as possible after collection.
4. Do not use icteric samples.
Reference range (1)Adults:22 - 29 mmol/l (mEq/l).
Storage and StabilityReagents, in unopened vials, are stable up to the expiry date on the
label if stored at 2 - 8 C protected from light and contamination is
avoided.
Once opened, the ABX Pentra CO2RTU reagentis stable for 28 dayswhen stored at 2-8C.
Do not freeze the reagent.
Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory reagents.
3. The reagent vials should be discarded after use.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 200 tests
Sample volume: 3 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (4)and equals 1.8 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 1 control are
tested 20 times according to the recommendations found in the Valtec
protocol (4).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 1 control are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (5).
Linearity and Measuring Range:The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (6).
Low linearity: 1.8 mmol/l
High linearity: 60.8 mmol/l, with automatic post-dilution: 121.6 mmol/l.
Correlation:
99 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-
A2 protocol (7).
The equation for the allometric line obtained is:
Y = 0.99 x + 0.35 with a correlation coefficient r2= 0.99.
Interferences:
Mean value mmol/l CV %
Normal control 20.4 1.25
Specimen 1 10.9 0.78
Specimen 2 21.3 0.51
Specimen 3 32.0 0.66
Mean value mmol/l CV %
Normal control 20.7 4.77
Specimen 1 9.5 7.7
Specimen 2 31.6 5.93
Haemoglobin: No significant influence is observed up to 195 mol/l
Triglycerides: No significant influence is observed up to 7 mmol/l
Total Bilirubin: No significant influence is observed up to 250 mol/l
Direct Bilirubin: No significant influence is observed up to 370 mol/l
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Calibration stability:The reagent is calibrated on H0. The calibration stability is checked by
testing 2 control specimens.
The calibration stability is 1 day by discarding the remaining reagent
at the end of the day.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application releasea: 3.xx
Warning
It is the users responsibility to verify that this document is applicableto the reagent used.
Reference1. Mller-Plathe O. Acid base balance and blood gases. In: Thomas L.,
editor. Clinical laboratory diagnostics. 1sted. Frankfurt: T.H. Books
Verlagsgesellschaft; 1998. p.318-329.
2. Norris K.A., Atkinson A.R., Smith W.G. Colorimetric enzymatic
determination of serum total carbon dioxide as applied to the
Vickers multichannel 300 discrete analyser. Clin. Chem. 1975;21;1093-1101.
3. US patent #5,801,006.
4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.5. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
7. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
a. Modification from index H to I: suppression of minor index.
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
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Creatinine CP
ABX Pentra
2007/07/04A93A00182M EN
A11A01666
28 ml
28 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
ABX Pentra Creatinine CPRef.: A11A01666Volume R1: 28 mlVolume R2: 28 ml
Diagnostic reagent for quantitative in-vitrodetermination of creatinine in serum,plasma and urine by colorimetry.
Clinical InterestCreatinine is a product of the degradation of the creatine. It is a tiny
nitrogenised molecule eliminated primarily by the kidneys. Under
stable conditions of the muscular mass and proteic contribution,
creatininaemia is an excellent reflection of renal function. The
determination of urinary creatinine permits the calculation ofclarification, which is an independent parameter of diuresis and
proteic contribution.
MethodMeasurement of the formation of a colorimetric complex between the
creatinine and the alkaline picrate (Jaff). The speed of the formation
of this complex is proportional to the creatinine present in the sample.
This kinetic method reduces the effects of interfering substances.
ReagentsABX Pentra Creatinine CPis ready-to-use.
ABX Pentra Creatinine CPshould be used according to this reagentnotice. HORIBA ABX cannot guarantee its performances if used
otherwise.
HandlingRemove both caps of the cassette. If present, remove foam by using a
plastic pipette. Position the respective protective cap, ref. GBM0969
on R1 and Ref. GBM0970 on R2 and place it in the position 45of theABX Pentra 400 reagent compartment.
Important : for a new cassette, wait for 30 minutes to stabilize thetemperature of the reagent.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml (lyophilisate)
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)
Reagent 1: Picric acid 8.73 mmol/l
Reagent 2: Sodium hydroxide 312.5 mmol/l
Disodium phosphate 12.5 mmol/l
ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x 10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals shouldcorrespond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry analyser
Standard laboratory equipment
Specimen Serum
Plasma in heparin and EDTA
Fresh centrifuged urine
Reference range(7)
We recommended that each laboratory establishes its own reference
range.
Men Women
Serum/Plasma: 8 - 13 6 - 12 mg/l
0.8 - 1.3 0.6 - 1.2 mg/dl
71 - 115 53 - 106 mol/l
Urine: 0.8 - 2.0 0.6 - 1.8 g/24 h
7.1 - 17.7 5.3 - 15.9 mmol/24 h
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Creatinine CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2-8 C and protected from light.
Stability opening: refer to the paragraph "Performance on ABX Pentra
400".
Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. Reagent, for professional in-vitrodiagnostic use only
2. The reagent 2 contains diluted sodium hydroxide and is
consequently irritating to the eyes and the skin. In case of contact
with eyes, rinse generously with water and consult a specialist.
Avoid all contact with the skin; use gloves when handling.
3. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 120 tests.
On board Reagent Stability:If the ABX Pentra Creatinine CP cassette is left on board theinstrument at all times, the cassette is stable for 21 days.
Sample volume: 13 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (4)
and equals 10 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (4).
Reproducibility (run-to-run precision)
A variance analysis out of 2 specimens of medium and high levels is
carried out (n=30).
Linearity and Measuring Range:The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (5).
Low linearity: 10 mol/l
High linearity: 1400 mol/l, with automatic post-dilution: 7000 mol/l.
Correlation:100 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9-
A2 protocol (6).
The equation for the allometric line obtained is:
Y = 1.08 x + 4.74 with a correlation coefficient r2= 0.993.
Interferences:
Conversion factor:mol/l x 0.113 = mg/l
mol/l x 0.0113 = mg/dl
Calibration stability:The reagent is calibrated each day.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application releasea: 4.xx
Urine
Number of tests: 120 tests.
On board Reagent Stability:If the ABX Pentra Creatinine CP cassette is left on board theinstrument at all times, the cassette is stable for 21 days.
Sample volume: 13 l/test
Detection limit:The detection limit is determined according to the Valtec protocol (4)
and equals 200 mol/l.
Mean value mol/l CV %
Normal control 114 1.58
Pathological control 299 0.66
Specimen 1 53 2.09
Specimen 2 137 0.71
Specimen 3 676 0.39
Mean value mol/l CV %
Specimen 1 111 2.35
Specimen 2 601 1.36
Haemoglobin: No significant influence is observed up to 319 mol/l
Triglycerides: No significant influence is observed up to 7 mmol/l
Total Bilirubin: No significant influence is observed up to 176 mol/l
Direct Bilirubin: No significant influence is observed up to 92 mol/l
Glucose: No significant influence is observed up to 22.5 mmol/l
a.Modification from index L to M: suppression of minor index.
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Creatinine CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
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Creatinine 120 CP
ABX Pentra
2007/06/28A93A01215C EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
A11A01868
1 x 27 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Creatinine 120 CPTest instructions for Mira instrumentsRef.: A11A01868Volume: 1 x 27 ml
Intended use
Diagnostic reagent for quantitative in-vitrodetermination of creatinine in serum, plasma andurine by colorimetry.
Clinical Interest (1,2)Creatinine, formed in the muscle, is a product of the degradation of
creatine phosphate, a high energy storage component. Creatininaemia
is quite constant (contrary to ureamia), it mainly depends of the
muscular mass. It is not very modified by food diet, age, sex or
exercise. Creatinine is extracted out of plasma by glomerular filtrationand then, eliminated in urine. The determination of urinary creatinine
permits the calculation of clarification, which is an independent
parameter of diuresis and proteic contribution.
Crea