PREGNANCY TEST ROMED CLEAR TEST

Pregnancy Test "Clear Test" Romed

HCG (Human Chorionic Gonadotropin) test is a one step lateral chromatographic immunoassay. The test consists of a conjugate pad containing monoclonal β-HCG antibodies conjugated to Colloidal gold and nitrocellulose membrane coated with monoclonal a-HCG antibodies on the test line region and goat IgG on the control line region.

Performance

The test is a qualitative immunoassay. When proper amount of urine specimen is applied to the sample well, the specimen migrates by capillary action through the test device. The T-line – a burgundy colored band in the test region, develops rapidly if the concentration is close to or higher than 25 mIU/ml in the specimen. No T line will develop if no HCG or lower than 25 mIU/ml is present in the specimen. The C line – a burgundy colored band in the control region of the test, should always appear regardless of the presence of HCG. It serves as an internal qualitative control of the test system.

Specification   4.0 mm

Physical examination               smooth appearance, firm attachment, complete content, liquid migration speed is not lower than 20 mm/min

Conformity rate of negative controls  Samples with detected concentration of 500 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 mIU/ml hTSH. Results must be negative

Confirmity rate of positive controls  Samples with detected concentration of 25 mIU/ml, 100 mIU/ML, 5 IU/ml and 200 IU/ml hCG. Results must be positive

Lowest detected conc.  Results can be read after 5 minutes. The lowest detected concentration shall be 25 mIU/ml

Precision  Detected using HCG standards with certain concentration (n=10), the results are consistent and with uniform colour development

Packing:

PT-MID1000: each device in a foil pack, 500 pieces in a plastic bag and 1000 pieces in an export carton.