Urine Dipstick Competency Challenge (POC3-B 2016) Dipstick Competency Challenge POC3-B 2016 Intended...

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© 2016 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes participants in the program to use the material in this Report solely for educational purposes within their own institutions. The College prohibits use of the material in the Report — and any unauthorized use of the College’s name or logo — in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Data from this program do not necessarily indicate the superiority or inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this Report, deceptive use of any such material, and any unauthorized use of the College’s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.

Surveys and Anatomic Pathology Education Programs

Urine Dipstick Competency ChallengePOC3-B 2016Intended Response

Osmolality - mOsm/kg (mmol/kg)

No. Labs Mean S.D. C.V.

POC

3-02

Advanced Instruments 855 951.9 6.0 0.6 ARKRAY 57 946.8 6.9 0.7 Fiske 70 957.0 6.3 0.7 Precision Systems 18 945.6 13.4 1.4

Urine hCG

The hCG level was intended to be positive.

POC

3-02

Manufacturer's Stated Sensitivity Level Manufacturer mIU/mL Negative Positive

Abbott TestPack Plus Combo w/ or w/out OBC - - 10 ACON One Step (urine only) - - 61 Alere hCG Cassette (20) (Acceava) - - 36 Alere hCG Cassette (25) (Clearview) - - 41 Alere hCG Combo Cassette (20/10) - - 91 Alere hCG Combo Cassette (25) (Clearview) - 1 65 Alere hCG Dipstick - - 13 Beckman Coulter ICON 20 - - 240 Beckman Coulter ICON 25 25 1 371 Cardinal Health SP Brand Cassette - - 172 Cardinal Health SP Brand Combo - - 834 Cen-Med Elite Plus One Step hCG - - 24 Clearview hCG Combo II - - 16 Consult Diagnostics Cassette - - 88 Consult Diagnostics Combo - - 40 Consult Diagnostics Dipstick - - 21 Eiken - - 12 Ekla Novaplus hCG Combo 20 - 13 Henry Schein OneStep+ Urine Cassette - - 17 Innovatek BioStrip - - 11 LifeSign Status (serum/urine) - - 15 Meridian ImmunoCard STAT - - 41 Polymedco Poly stat - - 31 Quidel QuickVue One-Step Combo - - 349 Quidel QuickVue One-Step Urine - - 375 Quidel QuickVue+ One-Step Combo 20 3 664 Quidel Sofia - - 20 Ramco Quik-Trak Combi Test (serum/urine) - - 10 SA Scientific (SAS) Ultra - - 15 SA Scientific (Serum/Urine) - - 20 Sekisui OSOM 25 - 63

1

Urine hCG (cont’)

The hCG level was intended to be positive

POC

3-02

Manufacturer's Stated Sensitivity Level Manufacturer mIU/mL Negative Positive

Sekisui OSOM Combo 20 1 215 Siemens Clinitek Status - - 263 Stanbio QuPID - 1 45 Stanbio QuPID PLUS - - 70 Stanbio True 20 Plus - - 24 Sure-Vue 25 - 108 Sure-Vue (Serum/Urine) 25 - 362 Sure-Vue STAT (Serum/Urine) 20 2 392 Technologist Choice (serum/urine) - - 14 Other and Methods with <10 responses - 5 667

2

Specific Gravity

POC

3-02

Method/Instrument No.

Labs

Mean

S.D.

C.V. ARKRAY Aution Sticks ARKRAY Aution Hybrid 32 1.0292 0.0015 0.1 ARKRAY Aution MAX 248 1.0258 0.0030 0.3 BioSys/Consult Diag/PSS Select/YD Diag Reagent

Strips

BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer

22 1.0239 0.0054 0.5

Eiken Uropaper Eiken US-3100R/3100Rplus 18 1.0329 0.0011 0.1 IRIS Mass Gravity Meter ARKRAY Aution MAX 13 1.0249 0.0032 0.3 Refractometer ARKRAY Aution MAX 82 1.0258 0.0031 0.3 Eiken US-3100R/3100Rplus 11 1.0331 0.0005 0.1 Visual 192 1.0295 0.0017 0.2 Roche Chemstrip/Combur Roche Chemstrip Criterion/II 57 1.0125 0.0030 0.3 Roche Chemstrip Urine Analyzer 12 1.0129 0.0026 0.3 Roche cobas u411, Urisys 1800 288 1.0133 0.0026 0.3 Roche Urisys 1100 227 1.0130 0.0029 0.3 Visual 198 1.0150 0.0021 0.2 Roche cobas u Pack Cassette Roche cobas u601 23 1.0298 0.0008 0.1 Roche Urisys Cassette Roche Urisys 2400 100 1.0292 0.0010 0.1 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas 438 1.0299 0.0011 0.1 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus 93 1.0312 0.0009 0.1 Siemens Reagent Strips Siemens Clinitek 50 30 1.0278 0.0034 0.3 Siemens Clinitek 500, Advantus 985 1.0258 0.0018 0.2 Siemens Clinitek Atlas 12 1.0298 0.0009 0.1 Siemens Clinitek Status 691 1.0284 0.0023 0.2 Visual 424 1.0259 0.0042 0.4 Method/Instrument No. Labs Median Low High Greater-Than Values Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas 77 1.030 1.030 1.030 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus 21 1.030 1.030 1.030 Siemens Reagent Strips Siemens Clinitek 10 or 100 25 1.030 0.300 1.030 Siemens Clinitek 50 38 1.030 1.030 1.030 Siemens Clinitek 500, Advantus 606 1.030 1.025 1.030 Siemens Clinitek Status 1382 1.030 0.030 1.300

Visual 15 1.030 1.030 1.030

3

pH, Urine

POC

3-02

Method/Instrument ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - - - - - 42 - - - - ARKRAY Aution JET - - - - - - 8 6 - - - - ARKRAY Aution MAX - - - - 1 4 6 339 1 - - - BioSys/Consult Diag/PSS

Select/YD Diag Reagent Strips

BioSys/Consult Diag/PSS

Select/YD Diag Urine Analyzer

- - - - - 14 15 1 - - - - Eiken Uropaper Eiken US-3100R/3100Rplus - - - - - - 25 12 - - - - Roche Chemstrip/Combur* Roche Chemstrip Criterion/II - - - - - - 15 44 - - - - Roche Chemstrip Urine Analyzer - - - - - - - 13 - - - - Roche cobas u411, Urisys 1800 - - - - - 3 78 236 - - - - Roche Urisys 1100 - - - - - 2 80 151 - - - - Visual** - - - 1 - 131 13 82 - - - - Roche cobas u Pack Cassette* Roche cobas u601 - - - - - - 3 20 - - - - Roche Urisys Cassette* Roche Urisys 2400 - - - - - - 7 100 - 1 - - Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - - - - 3 526 9 1 - - - Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - - - - - - 108 9 - - - - Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - - - - 13 25 - - - - Siemens Clinitek 50 - - - - - - 40 28 - - - - Siemens Clinitek 500, Advantus - - - - - 6 143 1545 5 - - - Siemens Clinitek Atlas - - - - - - 15 - - - - - Siemens Clinitek Status - 1 - - - 13 795 1340 3 - 2 - Visual - - - 1 - 9 264 210 11 3 - - Sysmex Reagent Strips Sysmex UX-2000 - - - - - - - 13 - - - -

* Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5.

** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed.

4

Protein – Qualitative, Method 1

POC

3-02

Method/Instrument

Negative Trace 1+ 2+ 3+ 4+

ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - - 17 - ARKRAY Aution MAX - - - 19 127 1 BioSys/Consult Diag/PSS Select/YD Diag

Reagent Strips

BioSys/Consult Diag/PSS Select/YD Diag

Urine Analyzer

- 1 - 3 13 10 Eiken Uropaper Eiken US-3100R/3100Rplus - - - 1 31 3 Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 1 24 1 Roche cobas u411, Urisys 1800 - 1 - 10 61 56 Roche Urisys 1100 - - - 2 34 41 Visual - - 2 70 129 1 Roche cobas u Pack Cassette Roche cobas u601 - - - 1 5 8 Roche Urisys Cassette Roche Urisys 2400 - - - 1 21 6 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - - 3 196 31 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - - 1 25 7 Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - 1 14 3 Siemens Clinitek 50 - - - 1 14 3 Siemens Clinitek 500, Advantus 1 - - 22 602 6 Siemens Clinitek Atlas - - - 1 9 1 Siemens Clinitek Status 1 - - 6 864 17 Visual - - 9 72 223 90

5

Protein – Qualitative, Method 2

Protein, Method 2 reporting options in SI units

Conventional (mg/dL) SI (g/L) Negative Negative 10-20 0.1 - 0.2 30-70 0.3 - 0.7 75 - Roche Users only 0.75 100 - 200 1.0 - 2.0 300 - 600 3.0 - 6.0 >600 or >1000 >6.0 or >1000

POC

3-02

Method/Instrument

Negative 10-20 mg/dL

30-70 mg/dL

75 mg/dL (Roche only)*

100-200 mg/dL

300-600 mg/dL

>600 or ≥1000 mg/dL

ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - - - 25 - ARKRAY Aution JET - - - - 2 11 - ARKRAY Aution MAX - 1 - - 36 167 1 Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - - 2 31 - Roche Chemstrip Urine Analyzer - - - - - 11 - Roche cobas u411, Urisys 1800 1 - - - 23 163 - Roche Urisys 1100 - - 1 - 6 153 - Visual - - 2 - 14 25 - Roche Urisys Cassette Roche Urisys 2400 - - - - 3 76 1 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas** - - - - 1 263 42 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - - - - 76 8 Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - - - 21 1 Siemens Clinitek 50 - - - - - 50 - Siemens Clinitek 500, Advantus 1 1 - - 37 1028 1 Siemens Clinitek Status 2 2 - - 8 1253 5 Visual - 1 1 - 34 125 67

* Not appropriate for Roche Urisys 1100 users. ** Clinitek Atlas users: for ≥ 300 mg/dL values report as 300-600 mg/dL.

6

Glucose, Method 1

POC

3-02

Method/Instrument Negative Trace 1+ 2+ 3+ 4+ ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - - 14 1 ARKRAY Aution MAX - - 1 2 120 6 BioSys/Consult Diag/PSS Select/YD Diag

Reagent Strips


Urine Analyzer

- - 2 8 9 8 Eiken Uropaper Eiken US-3100R/3100Rplus - - - - 34 - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 2 21 1 Roche cobas u411, Urisys 1800 - - - 7 37 77 Roche Urisys 1100 - - 1 - 24 52 Visual - - - 1 14 62 Roche cobas u Pack Cassette Roche cobas u601 - - - 1 11 2 Roche Urisys Cassette Roche Urisys 2400 - - - 10 10 6 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - 4 195 18 1 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - - 20 11 - Siemens Reagent Strips Siemens Clinitek 10 or 100 - - 3 10 2 2 Siemens Clinitek 50 - - - 10 5 1 Siemens Clinitek 500, Advantus 3 1 129 447 37 1 Siemens Clinitek Atlas - - - 9 1 1 Siemens Clinitek Status 11 2 14 822 20 1 Visual 2 4 24 107 55 24

7

Glucose, Method 2

Glucose, Method 2 reporting options in SI units

Conventional (mg/dL) SI (mmol/L) Negative Negative 30 - 100 1.6 - 6.0 150 - 300 8.3 - 16.6 500 28 >500 or >1000 or >2000 >28 or >55 or >111

POC

3-02

Method/Instrument

Negative 30-100 mg/dL

150-300 mg/dL

500* mg/dL

>500 or ≥1000

or ≥2000 mg/dL

ARKRAY Aution Sticks ARKRAY Aution Hybrid - - 1 26 1 ARKRAY Aution JET - - 4 9 - ARKRAY Aution MAX 2 - 63 145 12 Roche Chemstrip/Combur* Roche Chemstrip Criterion/II - - 8 1 26 Roche Chemstrip Urine Analyzer - 1 1 - 10 Roche cobas u411, Urisys 1800 1 - 30 1 163 Roche Urisys 1100 1 - 5 1 152 Visual - 2 2 15 142 Roche Urisys Cassette* Roche Urisys 2400 1 1 36 - 44 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - 1 8 291 19 Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - 1 1 68 17 Siemens Reagent Strips Siemens Clinitek 10 or 100 - - 2 16 5 Siemens Clinitek 50 - - - 28 24 Siemens Clinitek 500, Advantus 1 5 195 789 93 Siemens Clinitek Status 9 6 27 1206 38 Visual 1 4 32 188 157

*Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.

8

Reducing Substance

CM

-16

Method

Negative

¼% (Trace)

½%

¾%*

1%

≥2%

Bayer Clinitest, 2 Drop* - 1 1 1 10 87 Bayer Clinitest, 5 Drop 13 3 15 59 462 741

* Please note ¾% is not an appropriate response for the Bayer Clinitest, 2-drop method. Ketones, Method 1

POC

3-02

Method/Instrument Negative Trace Small Moderate Large ARKRAY Aution Sticks ARKRAY Aution MAX - - 18 - - Roche Chemstrip/Combur Visual - - 21 40 3 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - 19 - - Siemens Reagent Strips Siemens Clinitek 500, Advantus 2 1 45 3 - Siemens Clinitek Status 1 6 55 2 1 Visual 19 29 82 71 18

9

Ketones, Method 2

POC

3-02

Method/Instrument Negative Trace 1+ 2+ 3+ 4+ ARKRAY Aution Sticks ARKRAY Aution Hybrid - - 17 - - - ARKRAY Aution MAX - 1 145 2 - - BioSys/Consult Diag/PSS


BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer

- 2 19 4 - -

Eiken Uropaper Eiken US-3100R/3100Rplus 4 - 31 - - - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - 9 16 - - Roche cobas u411, Urisys 1800 - - 20 84 37 - Roche Urisys 1100 1 1 62 12 - - Visual 2 4 78 72 5 - Roche cobas u Pack Cassette Roche cobas u601 - - - 5 9 - Roche Urisys Cassette Roche Urisys 2400 - - 1 29 2 - Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - 2 228 - 1 - Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - 2 32 - - - Siemens Reagent Strips Siemens Clinitek 10 or 100 - 2 11 - - - Siemens Clinitek 50 - - 13 - - - Siemens Clinitek 500, Advantus - 36 574 4 - - Siemens Clinitek Atlas - - 10 - - - Siemens Clinitek Status 1 8 726 92 3 - Visual 9 15 50 21 2 2

10

Ketones, Method 3

Ketones, Method 3 reporting options in SI units

Conventional (mg/dL) SI (mmol/L) Negative Negative 5 -10 0.5 - 1.0 15 - 20 1.5 - 2.0 40 - 60 3.9 - 6.0 80 - 100 7.8 - 10.0 >150 >15.0

POC

3-02

Method/Instrument

Negative

5-10 mg/dL

15-25 mg/dL

40 - 60 mg/dL

80 - 100 mg/dL*

≥150 mg/dL

ARKRAY Aution Sticks ARKRAY Aution Hybrid - 6 18 - - - ARKRAY Aution JET - - 11 - - - ARKRAY Aution MAX - 82 103 1 - - Roche Chemstrip/Combur* Roche Chemstrip Criterion/II 1 - 14 16 - - Roche Chemstrip Urine Analyzer - - 4 7 - - Roche cobas u411, Urisys 1800 2 3 54 111 - - Roche Urisys 1100 2 2 124 25 2 1 Roche Urisys Cassette* Roche Urisys 2400 1 - 2 71 1 1 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - 5 284 1 - - Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - 6 69 - - - Siemens Reagent Strips Siemens Clinitek 10 or 100 - 4 17 - - - Siemens Clinitek 50 - - 51 1 - - Siemens Clinitek 500, Advantus 2 37 990 3 - - Siemens Clinitek Status 2 13 1158 89 1 - Visual 15 22 86 54 8 2

* Roche Urinalysis instruments should not report 80-100 mg/dL. Analyzers are not able to discern ketones between 60 and 150.

11

Bilirubin, Method 1

POC

3-02

Method/Instrument Negative Trace/Small Positive/Moderate Large ARKRAY Aution Sticks ARKRAY Aution Hybrid - - 1 12 ARKRAY Aution MAX 2 9 79 78 Roche Chemstrip/Combur Roche cobas u411, Urisys 1800 - - 15 10 Visual - - 21 11 Roche Urisys Cassette Roche Urisys 2400 - - 4 6 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas 3 292 21 - Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - - 78 1 Siemens Ictotest Visual 1 1 6 2 Siemens Reagent Strips Siemens Clinitek 10 or 100 - 1 9 16 Siemens Clinitek 50 - 2 49 3 Siemens Clinitek 500, Advantus 5 94 939 3 Siemens Clinitek Status 6 104 1132 8 Visual 8 12 52 263

Bilirubin, Method 2

POC

3-02

Method/Instrument Negative Trace 1+ 2+ 3+ 4+ ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - 1 13 - ARKRAY Aution MAX 1 - - 52 82 - BioSys/Consult Diag/PSS




- - 2 1 22 - Eiken Uropaper Eiken US-3100R/3100Rplus 1 - - - 35 - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 1 23 - Roche cobas u411, Urisys 1800 1 - - 4 119 1 Roche Urisys 1100 - - 1 1 68 - Visual 2 1 - 5 168 4 Roche cobas u Pack Cassette Roche cobas u601 - - - - 15 - Roche Urisys Cassette Roche Urisys 2400 - - - - 24 - Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas 3 1 197 6 - 1

12

Bilirubin, Method 2 (cont’)

POC

3-02

Method/Instrument Negative Trace 1+ 2+ 3+ 4+ Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - - - 34 - - Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - 5 7 - Siemens Clinitek 50 - - 1 11 - - Siemens Clinitek 500, Advantus 2 - 46 491 1 - Siemens Clinitek Atlas - - 10 - - - Siemens Clinitek Status - - 60 666 3 - Visual 3 1 3 19 82 3 Sysmex Reagent Strips Sysmex UX-2000 1 - - - 9 -

Bilirubin, Method 3

POC

3-02

Method/Instrument

Negative

0.5 -1.0 mg/dL

2.0 – 4.0 mg/dL

6.0 – 10.0 mg/dL

>10.0 mg/dL

ARKRAY Aution Sticks ARKRAY Aution Hybrid - 1 2 8 - ARKRAY Aution JET - - 4 7 - ARKRAY Aution MAX 2 2 15 22 - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 29 - Roche Chemstrip Urine Analyzer - - - 10 - Roche cobas u411, Urisys 1800 2 - 1 136 1 Roche Urisys 1100 1 - - 149 - Roche Urisys Cassette Roche Urisys 2400 1 - - 63 1

Blood or Hemoglobin, Method 1

POC

3-02

Method/Instrument

Negative Trace/Small Positive/Moderate

Marked Positive/Large

ARKRAY Aution Sticks ARKRAY Aution Hybrid - 1 9 1 ARKRAY Aution MAX - - 139 21 Roche Chemstrip/Combur Roche cobas u411, Urisys 1800 - - 12 4 Visual - - 13 6 Roche Urisys Cassette Roche Urisys 2400 - - 8 3 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - 1 15 286 Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - - 11 62

13

Blood or Hemoglobin, Method 1 (cont’)

POC

3-02

Method/Instrument

Negative Trace/Small Positive/Moderate

Marked Positive/Large

Siemens Reagent Strips Siemens Clinitek 10 or 100 - - 4 21 Siemens Clinitek 50 - 4 11 34 Siemens Clinitek 500, Advantus - 2 77 954 Siemens Clinitek Status 1 1 584 605 Visual - 2 19 345


POC

3-02

Method/Instrument

Negative

Trace

1+ 2+ 3+ 4+ 5+

ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - 18 3 1 - ARKRAY Aution MAX - - 1 130 21 - - BioSys/Consult Diag/PSS




- - 3 9 13 - - Eiken Uropaper Eiken US-3100R/3100Rplus - - - 4 32 - - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 2 24 1 - Roche cobas u411, Urisys 1800 - - - 3 61 59 3 Roche Urisys 1100 - - - 23 8 44 - Visual - - 5 24 35 16 - Roche cobas u Pack Cassette Roche cobas u601 - - - - 3 8 2 Roche Urisys Cassette Roche Urisys 2400 - - 1 6 19 1 - Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - - 12 218 4 - Siemens Clinitek Novus/Pro

Cassette

Siemens Clinitek Novus - - - 3 35 - - Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - 2 13 - - Siemens Clinitek 50 - - - 1 12 1 - Siemens Clinitek 500, Advantus 1 1 - 49 567 - - Siemens Clinitek Atlas - - - - 10 - - Siemens Clinitek Status 1 - 1 400 431 2 1 Visual - - 1 5 130 4 -

14


POC

3-02

Method/Instrument

Negative

5 – 25 Ery/µL

50 – 150 Ery/µL

250 Ery/µL

ARKRAY Aution Sticks ARKRAY Aution JET - - 8 3 Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - 28 - Roche Chemstrip Urine Analyzer - - 9 2 Roche cobas u411, Urisys 1800 1 - 158 10 Roche Urisys 1100 - - 6 155 Visual - - 54 76 Roche Urisys Cassette Roche Urisys 2400 - 1 65 3 Siemens Reagent Strips Siemens Clinitek 500, Advantus - 1 6 42 Siemens Clinitek Status - 1 61 75

15


POC

3-02

Method/Instrument

Negative

±0.03 mg/dL

0.06 – 0.10 mg/dL

0.20 – 0.50 mg/dL

≥1.0 mg/dL

ARKRAY Aution Sticks ARKRAY Aution MAX 1 - 2 29 4

Leukocyte Esterase, Method 1

POC

3-02

Method/Instrument Negative Trace Small Moderate Large ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - - 14 ARKRAY Aution MAX - - - 1 157 Roche Chemstrip/Combur Roche cobas u411, Urisys 1800 - - - 7 6 Visual - - - 6 6 Roche Urisys Cassette Roche Urisys 2400 - - - 2 8 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - 1 46 247 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - - 27 40 Siemens Reagent Strips Siemens Clinitek 10 or 100 - 2 8 14 1 Siemens Clinitek 50 - 1 36 4 10 Siemens Clinitek 500, Advantus - 6 113 908 12 Siemens Clinitek Status 9 42 864 56 209 Visual 1 24 123 191 20

16


POC

3-02

Method/Instrument Negative Trace 1+ 2+ 3+ 4+ ARKRAY Aution Sticks ARKRAY Aution MAX - 1 - 1 112 4 BioSys/Consult Diag/PSS Select/YD Diag

Reagent Strips


Urine Analyzer

2 - 4 7 11 - Eiken Uropaper Eiken US-3100R/3100Rplus - - - 4 23 - Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - 30 - - Roche cobas u411, Urisys 1800 - - - 54 76 - Roche Urisys 1100 - - - 27 47 1 Visual - 1 26 143 36 - Roche cobas u Pack Cassette Roche cobas u601 - - - 1 12 - Roche Urisys Cassette Roche Urisys 2400 - - - 14 12 1 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - 2 1 45 179 3 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - - 10 27 - Siemens Reagent Strips Siemens Clinitek 10 or 100 - - 5 8 2 - Siemens Clinitek 50 - - 7 2 5 - Siemens Clinitek 500, Advantus 2 3 60 540 6 - Siemens Clinitek Status - 20 648 54 115 1 Visual - 5 56 65 6 -

17


POC

3-02

Method/Instrument

Negative

25 µL

75 or 100 µL

250 or 500 µL

ARKRAY Aution Sticks ARKRAY Aution Hybrid - - - 19 ARKRAY Aution JET - - - 12 ARKRAY Aution MAX - - 2 72 Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - 1 26 Roche Chemstrip Urine Analyzer - - 1 9 Roche cobas u411, Urisys 1800 1 - 3 164 Roche Urisys 1100 - - 1 159 Roche Urisys Cassette Roche Urisys 2400 - - - 70 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - - 11 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - 3 10 Siemens Reagent Strips Siemens Clinitek 500, Advantus - - 43 5 Siemens Clinitek Status - 5 114 15

18

Nitrite

POC

3-02

Method/Instrument Negative Positive ARKRAY Aution Sticks ARKRAY Aution Hybrid - 42 ARKRAY Aution JET - 14 ARKRAY Aution MAX 1 349 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer 5 23 Eiken Uropaper Eiken US-3100R/3100Rplus - 29 Roche Chemstrip/Combur Roche Chemstrip Criterion/II - 59 Roche Chemstrip Urine Analyzer - 12 Roche cobas u411, Urisys 1800 3 310 Roche Urisys 1100 2 230 Visual 6 217 Roche cobas u Pack Cassette Roche cobas u601 - 23 Roche Urisys Cassette Roche Urisys 2400 - 107 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas 2 531 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - 118 Siemens Reagent Strips Siemens Clinitek 10 or 100 1 37 Siemens Clinitek 50 - 67 Siemens Clinitek 500, Advantus 2 1690 Siemens Clinitek Atlas - 15 Siemens Clinitek Status 3 2132 Visual 45 444 Sysmex Reagent Strips Sysmex UX-2000 - 12

19

Urobilinogen, Method 1

POC

3-02

Method/Instrument Negative 1+ 2+ 3+ 4+ ARKRAY Aution Sticks ARKRAY Aution Hybrid - 2 8 - - ARKRAY Aution MAX - 21 23 - - BioSys/Consult Diag/PSS




- 1 2 4 8 Eiken Uropaper Eiken US-3100R/3100Rplus - 9 18 - - Roche Chemstrip/Combur Roche cobas u411, Urisys 1800 - - - 11 65 Roche Urisys 1100 - - 1 - 66 Visual 1 2 22 27 9 Roche cobas u Pack Cassette Roche cobas u601 - - - 2 10 Roche Urisys Cassette Roche Urisys 2400 - - - 8 6 Siemens Reagent Strips Siemens Clinitek 500, Advantus - 1 2 12 15 Siemens Clinitek Status - 1 3 3 19 Visual - - - 10 35

20

Urobilinogen, Method 2

POC

3-02

Method/Instrument

Negative or

0.0 - 0.2 mg/dL

or <3.2 µmol/L

1.0 or

<2.0 mg/dL

or 16 µmol/L

or <35**

µmol/L

2.0/3.0 mg/dL

or 34 or ≥35 or

<70 µmol/L

4.0 or

4.0/6.0 mg/dL

or ≥70 or <140

µmol/L

≥8.0 or

12.0 mg/dL

or ≥140 or

200 µmol/L ARKRAY Aution Sticks ARKRAY Aution Hybrid - - 8 21 - ARKRAY Aution JET - - 3 10 - ARKRAY Aution MAX 1 3 100 189 1 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips

BioSys/Consult Diag/PSS Select/YD

Diag Urine Analyzer - - - 1 13

Roche Chemstrip/Combur Roche Chemstrip Criterion/II - - - - 53 Roche Chemstrip Urine Analyzer - - - - 11 Roche cobas u411, Urisys 1800 1 2 - 2 220 Roche Urisys 1100 1 - 1 1 157 Visual 1 4 1 23 118 Roche cobas u Pack Cassette Roche cobas u601 - 1 - - 9 Roche Urisys Cassette Roche Urisys 2400 1 - - 1 89 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas - - 16 391 75 Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus - - 5 73 29 Siemens Reagent Strips Siemens Clinitek 10 or 100 - - - - 31 Siemens Clinitek 50 1 - 1 9 51 Siemens Clinitek 500, Advantus 2 - - 58 1386 Siemens Clinitek Atlas - - 1 11 1 Siemens Clinitek Status 3 - 1 190 1606 Visual - 1 2 32 345

**Note: <35 µmol/L for ARKRAY Aution MAX users only.

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Urine Dipstick Competency Challenge (POC3-B 2016) Dipstick Competency Challenge POC3-B 2016 Intended...

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