Sensitivity
CHECK-MATE urine dip-strips will detect HCG in urine with concentrations greater than 25 mIU/ml. The test has been standardized to World Health Organisation 1st IRP / 3rd IS 75 / 537.
Materials Provided
Test devices (test strips) sealed in an aluminium pouch with desiccant. Each dip-strip is used to perform one test only.
Accuracy
Positive correlation of more than 99% was found testing random urine samples, as compared to a commercially available HCG IRMA (Serono MAIA) kit.
Specimen Collection
For optimal results it is best to test the first urine voided in the morning because it contains the greatest concentration of HCG. However, specimen urine collected anytime during the day can be used. Specimens can be stored at 2 o C to 8 o C for up to 48 hours, or below -20 o C for at least 3 months. Specimens should not be frozen and thawed repeatedly. Thawed specimens should be inverted several times just prior to testing. Urine samples containing excessive bacterial contamination should not be used.
Precautions
1. For in-vitro diagnostic use.
2. Do not use the reaction units after the expiry date.
3. All patient samples should be handled as if they were capable of transmitting disease.
Quality Control
A built-in control is included in the test. In addition, in accordance with good laboratory practice, negative and positive controls should be used with each assay. Such controls are available commercially.
Expected Values
HCG is not normally detected in the urine of healthy men and healthy non-pregnant women. The sensitivity of CHECK-MATE HCG Urine is 25 mIU/ml (WHO, 1st IRP). In normal pregnancy, HCG levels in urine can reach 25 mIU/ml (1st IRP) as early as 10 days post-conception, approximately 3 days before the expected period. CHECK-MATE dip-strips can therefore be used to determine pregnancy as early as the first day of the missed period. HCG levels continue to increase exponentially to reach a maximum concentration in excess of 200,000 mIU/ml at the end of the first trimester.
Cross Reactivity
HCG-free urine samples containing 500 mIU/ml of the glycoprotein LH & 1,000 mIU/ml of the glycoproteins FSH & TSH gave negative results.
