Item Brochure

EXPECTED VALUES
hCG is not normally detected in the urine and serum specimens of healthy men and non-pregnant
women. In normal pregnancy, 20 mIU/mL hCG is reported to be present in both urine and serum
2 to 3 days before the first missed menstrual period.
(15,16)
The levels of hCG continue to increase
up to 200,000 mIU/mL at the end of the first trimester.
Agreement
Urine specimens from 634 individuals were evaluated with the OSOM Card Pregnancy Test and the
QuickVue
®
+ One-Step hCG-Combo Test. Samples were from patients seeking confirmation of pregnancy.
The two assays were in agreement on 629 of the 634 samples. A radioimmunoassay (DPC Coat-A-Count
®
hCG IRMA Kit) was used to quantify the five discrepant results. Three of the discrepant samples were
found to have an hCG concentration greater than 0 but less than 20 mIU/mL, the stated analytical
sensitivity of both assays, and thus were removed from the analysis. One sample contained 0 mIU hCG/
mL according to the IRMA and was scored negative by the OSOM test but positive by QuickVue+. The
remaining sample contained >500 mIU hCG/mL according to the IRMA and was scored positive by the
OSOM test but negative by QuickVue+.
Thus in this study, the OSOM hCG urine procedure had greater than 99% agreement with the comparative
test methods in the 435 specimens testing negative and the 196 specimens testing positive.
Physician’s Office Laboratory (POL) and Laboratory Study
A proficiency panel was prepared to allow for the evaluation of the urine testing format at three
physician’s office and a clinical laboratory. A total of 40 samples were tested at each site. Purified
hCG was spiked into an artificial urine matrix. Each panel contained negative, low positive, moderate
positive and high positive samples. Each panel was tested at each site over the course of three distinct
runs. 100% of the positive and negative results obtained by the POL operators were in agreement with
the expected values and with the results obtained by the clinical laboratory operators.
PERFORMANCE CHARACTERISTICS
Sensitivity
The OSOM Card Pregnancy Test will detect hCG in urine specimens with concentrations of 20 mIU/mL
or more (calibrated against WHO 3rd IS 75/537). Specimens containing 1,000,000 mIU/mL (spiked with
purified hCG) will also give positive results.
• The expected sensitivity of urine samples at a read time of 3 minutes is 20 mIU/mL
Note: Samples containing minute quantities of hCG (below 10 mIU/mL) may develop faint test bands.
Urine
120%
100%
80%
60%
40%
20%
0%
0 5 10 20 30
% of samples containing varying amounts
of hCG interpreted as positive
Comparative Methods
(QuickVue+ Test and IRMA)
+ –
OSOM
®
Card
Pregnancy
Test
+ 196 0
– 0 435
Agreement on Positive Samples: >99%
Agreement on Negative Samples: >99%
Total Agreement: >99%