ToRCH Toxo/Rubella/CMV/HSV 1/2 IgM Antibodies Combo Test

 INTENDED USE

The ToRCH IgM Antibodies Combo Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Toxoplasma gondii (Toxo), Rubella virus (Rubella), Cytomegalovirus (CMV), and Herpes simplex virus 1/2 (HSV 1/2) in serum or plasma to aid in the diagnosis of ToRCH.

SUMMARY

ToRCH is an acronym for a group of infectious diseases that, while infecting the pregnant women, may cause birth defects in their newborns.1 ToRCH stands for 4 different infections that can adversely affect the pregnant women and the fetus, newborn children including birth defects and often leading to abortion. The four infections are Toxomplasma gondii (A spirochete), Rubella (Virus), CMV – Cytomegalovirus (Virus), HSV 1/2 – Herpes Simplex Virus 1 and/or 2 (Virus). The infections usually cause few, if any, symptoms in the pregnant woman, but pose greater risks of serious birth defects for neonates. Infections caused by ToRCH – Toxoplasma, Rubella Virus, Cytomegalo Virus (CMV) and Herpes Simplex Virus (HSV) – is the major cause of BOH (Bad Obstetric History).2
Risks are severe, if the mother gets the infection in the first trimester as the baby’s organs start to form in this stage. General symptoms include premature birth, growth retardation, neurological abnormalities, damage of the eye, liver, heart and ear as well as bone lesions. Microcephaly, hydrocephaly, seizures and psychomotor retardation accompany these malformations.
The ToRCH IgM Antibodies Combo Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Toxo, Rubella, CMV, and HSV 1/2 in serum or plasma specimens.

PRINCIPLE

The ToRCH IgM Antibodies Combo Rapid Test Device (Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgM antibodies to Toxo, Rubella, CMV, and HSV 1/2 in serum or plasma specimens. In this test, antigens of Toxo, Rub, CMV and HSV 1/2 are coated in the test line regions of each section in the test. During testing, the serum or plasma specimen reacts with Goat anti-human IgM coated particles in the test strip. The mixture then migrates upward on the membrane by capillary action and reacts with the Toxo, Rub, CMV and HSV
1/2 specific antigens on the membrane in the test line regions of the respective sections. The presence of a colored line in the test line region of a particular section indicates a positive result for the corresponding infection, viz. Toxo, Rub, CMV, HSV 1/2, while its absence indicates a negative result for that infection. To serve as a procedural control, a colored line will always appear in the respective control line regions of all the four strips indicating that proper volume of specimen has been added and membrane wicking has occurred.