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FINAL PATIENT AND SPECIMEN INFORMATION Patient Name: Example Patient ID: PT0000703 Sex: Female DOB: Jul-07-1960 TRF ID: TR11050101CI Collection Date: Sep-05-2014 Receipt Date: Sep-06-2014 PHYSICIAN AND REPORT INFORMATION Ordering MD: Example Clinic: ABC Clinic Phone: 555-555-5555 Fax: Report Date: Sep-09-2014 877-743-8640 19 ( 95% Range*: 16.5 – 21.5) Vectra DA measures the concentrations of 12 serum proteins. An algorithm is applied to these concentrations to calculate a quantitative disease activity score ranging from 1 to 100. Test results are intended to aid in the assessment of disease activity in RA patients when used in conjunction with standard clinical assessment. This test is not intended or validated to diagnose RA. Test Description: Vectra DA Score = *The range reflects the precision of the score based on repeat measurements. (Eastman, et al., J Pharm Biomed Anal. 2012 Nov;70:415-24) TEST RESULTS The Vectra DA test is intended for clinical use; it was developed and its performance characteristics determined by Crescendo Bioscience, Inc. The Crescendo Bioscience Clinical Laboratory is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing. Crescendo Bioscience Clinical Laboratory • 341 Oyster Point Boulevard • South San Francisco, CA 94080 • www.crescendobio.com Toll-Free 1-877-RHEUMDX (1-877-743-8639) • Fax: 1-877-743-8640 Vectra DA Disease Activity Levels: Low: 1 to 29 Moderate: 30 to 44 High: 45 to 100 Page 1 of 2 ML-TR-09 3/15 Laboratory Director: Russell Kerschmann, MD; Meredith Halks Miller, MD, FCAP (NY) Laboratory I.D. No. CLF339225 CLIA No. 05D1106964 SPECIMEN COLLECTION DATE 100 90 80 70 60 50 40 30 20 10 0 High Moderate Low VECTRA DA SCORE OCT-01–2013 55 DEC 02–2013 35 MAR-02–2014 20 SEP-05–2014 19 EXAMPLE ONLY ONLY Clinical Validation: Vectra DA was validated in adults with rheumatoid arthritis (RA), 230 who previously tested positive for rheumatoid factor (RF) and/or antibodies to cyclic citrullinated peptide (anti-CCP) and 141 who tested negative for both RF and anti-CCP. The perfor- disease activity thresholds shown in the graph and below reflect the Vectra DA score equivalents to DAS28CRP cut-offs of 2.67 (low to mance of the test may differ between these two populations. (Curtis et al. Arthritis Care Res. 2012; 64 (12):1794-1803). The Vectra DA moderate) and 4.09 (moderate to high), respectively (Inoue et al. Ann Rheum Dis the DAS28 scale (0-9.4) to the Vectra DA scale (1 to 100). 2007;66: 407-409), and were calculated by converting
Transcript of Download a test report here
FINAL
PATIENT AND SPECIMEN INFORMATION
Patient Name: ExamplePatient ID: PT0000703Sex: FemaleDOB: Jul-07-1960TRF ID: TR11050101CICollection Date: Sep-05-2014Receipt Date: Sep-06-2014
PHYSICIAN AND REPORT INFORMATION
Ordering MD: ExampleClinic: ABC Clinic
Phone: 555-555-5555Fax:
Report Date: Sep-09-2014
877-743-8640
19 ( 95% Range*: 16.5 – 21.5)
Vectra DA measures the concentrations of 12 serum proteins. An algorithm is applied to these concentrations tocalculate a quantitative disease activity score ranging from 1 to 100. Test results are intended to aid in the assessment of disease activityin RA patients when used in conjunction with standard clinical assessment. This test is not intended or validated to diagnose RA.
Test Description:
Vectra DA Score =
*The range reflects the precision of the score based on repeat measurements. (Eastman, et al., J Pharm Biomed Anal. 2012 Nov;70:415-24)
TEST RESULTS
The Vectra DA test is intended for clinical use; it was developed and its performance characteristics determined by Crescendo Bioscience, Inc. The Crescendo Bioscience ClinicalLaboratory is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing.
Crescendo Bioscience Clinical Laboratory • 341 Oyster Point Boulevard • South San Francisco, CA 94080 • www.crescendobio.comToll-Free 1-877-RHEUMDX (1-877-743-8639) • Fax: 1-877-743-8640
Vectra DA Disease Activity Levels: Low: 1 to 29 Moderate: 30 to 44 High: 45 to 100
Page 1 of 2ML-TR-09 3/15 Laboratory Director: Russell Kerschmann, MD; Meredith Halks Miller, MD, FCAP (NY) Laboratory I.D. No. CLF339225 CLIA No. 05D1106964
SPECIMEN COLLECTION DATE
100
90
80
70
60
50
40
30
20
10
0
High
Moderate
Low
VEC
TRA
DA
SCO
RE
OCT-0
1–20
13
55
DEC 02–
2013
35
MAR-0
2–20
14
20
SEP-
05–2
014
19
EXAMPLE ONLYONLY
Clinical Validation: Vectra DA was validated in adults with rheumatoid arthritis (RA), 230 who previously tested positive for rheumatoidfactor (RF) and/or antibodies to cyclic citrullinated peptide (anti-CCP) and 141 who tested negative for both RF and anti-CCP. The perfor-
disease activity thresholds shown in the graph and below reflect the Vectra DA score equivalents to DAS28CRP cut-offs of 2.67 (low tomance of the test may differ between these two populations. (Curtis et al. Arthritis Care Res.2012; 64 (12):1794-1803). The Vectra DA
moderate) and 4.09 (moderate to high), respectively (Inoue et al. Ann Rheum Disthe DAS28 scale (0-9.4) to the Vectra DA scale (1 to 100).
2007;66: 407-409), and were calculated by converting
FINAL
PATIENT AND SPECIMEN INFORMATION
Patient Name: ExamplePatient ID: PT0000703Sex: FemaleDOB: Jul-07-1960TRF ID: TR11050101CICollection Date: Sep-05-2014Receipt Date: Sep-06-2014
PHYSICIAN AND REPORT INFORMATION
Ordering MD: ExampleClinic: ABC Clinic
Phone: 555-555-5555Fax:
Report Date: Sep-09-2014
877-743-8640
UnitsResult RA Range* RA Percentile
Adhesion Molecules45.01-MACV μg/mL 0.35-1.1 40%
Growth Factors%18083-12 Lm/gp042FGE §
VEGF-A 460 pg/mL 83-780 84%
Cytokine-related Proteins%02001-2.2 Lm/gp1.56-LI
%65.4-1.1 Lm/gn3.1IR-FNT
Matrix Metalloproteinases%8193-1.3 Lm/gn7.51-PMM
%97031-2.9 Lm/gn153-PMM
Skeletal-related Proteins%4044-62 Lm/gn8204-LKY
Hormones%3654-0.1 Lm/gn41nitpeL
%591-6.3 Lm/gn1.4nitsiseR
Acute Phase Proteins6.1AAS μg/mL 0.64-100 19%
%9277-42.0 L/gm3.2PRC
* These ranges were established using 512 RA patient samples from the InFoRM study (Ann Rheum Dis 2010; 69 (Suppl 3); 657),except for leptin for which 112 non-obese RA patient samples were used.
† Subject's biomarker level relative to levels in RA patient specimens from which the RA range was determined.§ Inversely correlated with disease activity
Please note: The individual biomarker results, which are expressed to two significant figures, are required inputs into the algorithm
INDIVIDUAL BIOMARKER RESULTS
used to calculate the Vectra DA Score. Clinical interpretation of individual biomarker levels, which have different weights in the
†
Vectra DA algorithm, has not been established.
2Page 2 ofML-TR-09 3/15 Laboratory Director: Russell Kerschmann, MD; Meredith Halks Miller, MD, FCAP (NY) Laboratory I.D. No. CLF339225 CLIA No. 05D1106964
The Vectra DA test is intended for clinical use; it was developed and its performance characteristics determined by Crescendo Bioscience, Inc. The Crescendo Bioscience ClinicalLaboratory is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing.
Crescendo Bioscience Clinical Laboratory • 341 Oyster Point Boulevard • South San Francisco, CA 94080 • www.crescendobio.comToll-Free 1-877-RHEUMDX (1-877-743-8639) • Fax: 1-877-743-8640
EXAMPLE ONLY
