Format: | Cassette | Specimen: | Whole Blood,serum,plasma(ITOM-445) Serum,plasma(ITOM-435) |
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Kit Size: | 25T/Kit | Cut-Off: | See Insert |
Storage: | 2-30℃ | Shelf Time: | 24 Months |
Highlight: | lateral flow test strips,lateral flow diagnostics |
A rapid test 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 human whole blood, serum or plasma CE certified
Applications:
ToRCH IgM Combo Rapid Test Cassette 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 whole blood, serum or plasma to aid in the diagnosis of ToRCH.
Description:
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, and 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 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Toxo, Rubella, CMV, and HSV 1/2 in whole blood, serum or plasma specimens.
How to use?
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 10μl). Transfer the specimen to the each specimen well, then add 2 drops of buffer (approximately 80μl) and start the timer. See the illustration below.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:
Toxo Positive: *Two colored lines appear in the “Toxo” section. One line should be in the control line region (C) and another line should be in the test line region (T).
Rubella Positive: *Two colored lines appear in the “Rub” section. One line should be in the control line region (C) and another line should be in the test line region (T).
CMV Positive: *Two colored lines appear in the “CMV” section. One line should be in the control line region (C) and another line should be in the test line region (T).
HSV 1/2 Positive: *Two colored lines appear in the “HSV 1/2” section. One line should be in the control line region (C) and another line should be in the test line region (T).
*Note: The intensity of the color in test line region (T) will vary depending on the concentration of IgM antibodies present in the specimen. Therefore, any shade of color in test line region (T) should be considered positive.
NEGATIVE:
One colored line appears in the control line region (C) of every section. Non-appearance of a visible line in the test line region (T) of any section is indicative of a negative test result for that specific section, viz. Toxo, Rub, CMV, and HSV 1/2.
INVALID:
Control line fails to appear in any section. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.