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.

.

Special Instructions

• The AmniSure test kit is intended for in vitro diagnosis only. No components should be ingested.
• Read and follow the instructions carefully. Failure to follow test instructions may lead to inaccurate results.
• Please follow precautions during biomaterial collection, handling, and disposal.
• Damaged test components should not be used.
• Tests used are biohazardous.
• Take the necessary precautions when handling used tests.
• Do not use the tests after the date indicated on the kit package and on the box.
• Do not reuse test components.
• Do not bend or crumple the test strip or aluminum foil package that contains the test strip.
  

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:

• AmniSure test strip in a foil bag with moisture absorbent.
• Secure vaginal polyester swab.
• Plastic test tube with solvent.
• Instruction.

Specifications

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

• Sensitivity: 98.9%.
• Specificity: 100%.
• Positive diagnostic significance: 100%.
• Negative predictive value: 99.1%.