ACUR Test hCG (Rapid Test Card)

For the rapid detection of Human Chorionic Gonadotropin (hCG) in urine specimens. This test kit is used to obtain a visual, qualitative result and is intended by professional and laboratory use only.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after implantation. hCG can be detected in the urine and serum of pregnant women as early as 6 to 15 days after conception. The concentration of hCG increases to 50 mlu/ml one week post implantation and reaches to about 100 mlu/ml at the time of the first missed menstrual period and the peak at 100,000-200,000 mlu/ml at the the first trimester.

The ACUR hCG test card is a rapid test to detect the presence of hCG in urine specimens in a qualitative format Sensitive to 20 mlu hCG / ml. The test utilises a combination of monoclonal and polyclonal antibodies reagents to selectively detect elevated level of hCG in urine. The immunological specificity of the test card virtually eliminates cross reactivity interferences from the structurally related glycoprotein hormones FSH, LH, TSH at physiological levels.

The test card can be stored at room temperature max. 30° upto the expiry date. The test card should be kept away from direct sunlight, moisture and heat.

The urine specimen must be collected in a clean & dry container, either plastic or glass. It is preferable to use First morning urine as specimen, as it generally contains the highest concentration of hormone. Urine specimen may be refrigerated (2-S0C) and stored upto 72 hours prior to assay. If sample is refrigerated, they must be equilibrated to room temperature (25-300C) before testing. Urine sample exhibiting visible precipitates should be filtered, centrifuged or allowed to settle and clear specimen should be obtained for testing.

Review "Specimen Collection" instructions. Test device, patient's sample and controls should be brought to room temperature (25-300C) prior to testing. Do not open pouches until ready to perform the assay.

It is recommended that two levels of positive control specimens and one negative control specimen be used with each new kit, for validation of results and quality control procedures.

Sensitivity and Specificity:
The ACUR hCG card detects urine hCG concentrations greater than 20 mlu / ml. as indicated by the appearance of a colour band at the test region.

Specificity of the ACUR card has been determined from cross reaction studies with known amounts of Luteinizing hormone (LH), Follicle stimulating hormone (FSH) and Thyroid stimulating hormone (TSH) 300 mIu LH/ml and 1,000 mIu TSH/ml all give negative results.

The following substances were added in hCG free and 50 mlu/ml. hCG spiked urine samples. At the concentrations tested, none of the substances interfered in the assay.