Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro qualitative detection of placental alpha-1-microglobulin (PAMG-1) in human vaginal secretion specimens. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

Placental alpha 1 microglobulin (PAMG-1) is a fetal glycoprotein expressed by placental decidual cells, with a low concentration in blood but a high concentration in amniotic fluid [1]. When maternal premature rupture of membranes (PROM) did not occur, the concentration of PAMG-1 in cervicovaginal secretions was extremely low. When maternal premature rupture of membranes (PROM) occurred, the concentration in cervicovaginal secretions increased significantly. The concentration difference of premature rupture of membranes is as high as 1000-10000 times [2], and PAMG-1 is not affected by factors such as cervical mucus, blood, and urine of pregnant women. Therefore, PAMG-1 has become an important sign to assist in the diagnosis of premature rupture of membranes [3].

The current clinical methods for detecting PAMG-1 include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST PARAMETER
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® PAMG-1
Format	Cassette	Reaction Time	10min
Linearity	-	Reference Interval	Negative < 100 Positive ≥ 100
Sample	vaginal secretions	Certificate	CE

ORDERING
Cat. No.	LMPEPA25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LAPEPA25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T