Product Manual

tested before using a new lot, untrained operator or a new shipment of kit as good laboratory testing
practice and that users follow federal, state, and local guidelines for quality control requirements. For
information on how to obtain controls, contact Sekisui Diagnostics Technical Service: Tel [phone]
(U.S. Customers only).
EXPECTED VALUES
OSOM Ultra hCG Combo Test is capable of detecting hCG levels of 25 mIU/mL (WHO 3rd International
Standard). HCG levels in normal early pregnant women vary and hCG levels often exceed 100 mIU/
mL by the first day of the missed menstrual period.
1
The test is usually capable of detecting hCG by the
first day of the missed menstrual period.
PERFORMANCE CHARACTERISTICS
Clinical Evaluation-Urine Assay
A total of 247 blind clinical urine samples were studied. These specimens were assayed with OSOM
Ultra hCG Combo Test and Tandem
®
Icon™ II according to the package inserts (Table 1). Thirty-six
(36*) samples are from menopausal women
TABLE 1 (URINE ASSAY)
OSOM Ultra hCG Combo Test vs. Tandem
®
Icon™ II with Urine Specimens
TEST RESULT (# OF SAMPLES)
Tandem
®
Icon™ II OSOM Ultra hCG Combo
Positive 78 78
Negative 133 133
Menopausal Not Determined 36 (Negative)
The data demonstrate the excellent correlation between OSOM Ultra hCG Combo Test and
Tandem
®
Icon™ II. The clinical accuracy and sensitivity of the two tests are found comparable.
Overall Accuracy: 100%
Relative Sensitivity: 100%
Relative Specificity: 100%
Clinical Evaluation—Serum Assay
A total of 425 blind clinical serum samples were studied. These specimens were assayed with
OSOM Ultra hCG Combo Test and Tandem
®
Icon™ II according to the package inserts. The
results demonstrate 100% relative sensitivity, 99% relative specificity and 99.5% overall accuracy
(Table 2).
TABLE 2 (SERUM ASSAY)
OSOM Ultra hCG Combo Test vs. Tandem
®
Icon™ II with Serum Specimens.
TEST RESULT (# OF SAMPLES)
Overall Accuracy: 99.5%
Relative Sensitivity: 100%
Relative Specificity: 99%
PHYSICIANS’ OFFICE LABORATORY EVALUATION (Proficiency Study)
Reproducibility of OSOM Ultra hCG Combo test results was evaluated at three physicians’ office
laboratories using a total of 120 blind control samples. The control panels were prepared in serum or
urine. Each panel consisted of 5 negative (–), 5 low positive (25 mIU/mL hCG), 5 moderate positive
(200 mIU/ mL hCG), and 5 high positive (500mIU/mL hCG) samples. The results obtained at each site
agreed 100% with expected results and with predicate tests compared in parallel.
Sensitivity- Urine Assay
Standard controls (calibrated to the WHO 3rd International Standard) ranging from 5 mIU/mL to
40 mIU/mL in urine were tested in 20 replicates. The results confirmed sensitivity of 25 mIU/mL.
Tandem
®
Icon™ II
+ -
OSOM Ultra hCG Combo
(Serum/Urine)
Positive 215 2
Negative 0 208
Total 215 210