AmniShua ROM test/AmniSure ROM Test Kit, 1 Tube

AmniSure is a one-step enzyme immunoassay. It uses a system of three monoclonal antibodies to detect PAMG-1. AmniSure works over a wide range of PAMG-1 concentrations in vaginal secretions (from 5 ng/ml to 100 mg/ml). The high accuracy of the test is maintained even with minor leaks of amniotic fluid.

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Special Instructions

Features

AmniSure is a one-step enzyme immunoassay. It uses a system of three monoclonal antibodies to detect PAMG-1. AmniSure works over a wide range of PAMG-1 concentrations in vaginal secretions (from 5 ng/ml to 100 mg/ml). The high accuracy of the test is maintained even with minor leaks of amniotic fluid.

The clinical efficacy of the AmniSure test has been confirmed by a number of studies in which it was compared to a clinical diagnosis that was a combination of nitrazine test, crystallization test and speculum examination. The diagnosis was made when the results of two of the three tests matched. A total of 432 patients with gestational ages ranging from 11 to 41 weeks participated in the study. Compared to clinical diagnoses based on conventional diagnostic methods.

The test system uses highly sensitive monoclonal antibodies to detect even the smallest amount of protein present in the vaginal discharge when the fetal membranes rupture. To minimize the incidence of false results, two monoclonal antibodies were chosen to set the AmniSure sensitivity threshold at an optimally low level. This level allows the detection of extremely small amounts of amniotic fluid in the vaginal discharge. Background concentrations of PAMG-1 are about 50-220 picograms (i.e., 0.05-0.22 ng) in 1 ml of secretions. The sensitivity of the AmniSure test is 5 ng/ml, i.e., at least 20 times higher than the background concentration. This is what makes AmniSure highly accurate.

Complete set

The kit includes:

Specifications

This clinical study served as the basis for FDA approval of AmniSure in the United States and yielded the following results: