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 for in vitro diagnostic use only. No components should be ingested.
Read and follow the instructions exactly. Failure to follow testing instructions may result in inaccurate results.
Observe safety precautions when collecting biomaterial, handling the test, and disposing of it.
Damaged test components should not be used.
The tests used are biohazardous.
Take necessary precautions when handling used tests.
Do not use tests after the date indicated on the kit packaging and on the box.
Do not reuse test components.
Do not bend or crease the test strip or the aluminum foil package that contains the test strip.

Functional features

AmniSure is a one-step enzyme immunoassay. A system of three monoclonal antibodies is used to detect PAMG-1. AmniSure works over a wide range of PAMG-1 concentrations in vaginal fluid (5 ng/mL to 100 mg/mL). The high accuracy of the test is maintained even with slight leakage of amniotic fluid.

The clinical effectiveness of the AmniSure test is supported by a number of studies in which it was compared with a clinical diagnosis, which is a combination of the nitrazine test, crystallization test and speculum examination. The diagnosis was made when the results of two out of three tests coincided. The studies involved 432 patients with a gestational age ranging from 11 to 41 weeks. Compared with clinical diagnoses based on conventional diagnostic methods.

The test system uses highly sensitive monoclonal antibodies that can detect even minimal amounts of protein present in the vaginal discharge during rupture of the membranes. To minimize the incidence of false results, two monoclonal antibodies were selected to set AmniSure’s sensitivity threshold at an optimally low level. This level allows the detection of extremely small amounts of amniotic fluid in vaginal fluid. The background concentration of PAMG-1 is 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 background concentration. This is what determines the high accuracy of AmniSure.

Specifications

This clinical trial served as the basis for FDA clearance of AmniSure in the United States and produced the following results:

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

Prescribing

The test is intended to be used as a means of determining the presence of ruptured membranes in pregnant women suspected of having such ruptures.

Complete set of goods

The set includes:

AmniSure test strip in foil pouch with moisture absorber.
Sterile polyester vaginal tampon.
Plastic test tube with solvent.
Instructions.

Manufacturer

AmniShua, USA