ToRCH IgM Rapid Test device , 4mm cassette, gold colloidal method,Blood test, easily use


Intended Use:

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.

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, 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 IgG antibodies and IgM antibodies to Toxo, Rubella, CMV, and HSV 1/2 in whole blood, serum or plasma specimens.

TEST PRINCIPLE

Toxo IgM Rapid Test:

In this test, mouse anti-human IgM are coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with T.gondii antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-human IgM on the membrane in the test line region respectively. The presence of a colored line in the test line region indicates a positive result for T.gondii infection, while its absence indicates a negative result for that infection.

Rubella IgM Rapid Test/CMV IgM Rapid Test/HSV 1/2 IgM Rapid Test:

In this test, antigens of Rub, CMV and HSV 1/2 are coated in the test line regions of each section in the test. During testing, the whole blood, 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 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. 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.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS


Positive:
Two red lines are visible in the result window. The intensity of the test line may be
weaker or darker than that of the control line. This still means a positive result.

Negative:
The control line appears in the result window, but the test line is not visible.

Invalid:
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ToRCH IgM Combo Rapid Test Cassette was compared with leading commercial EIA Toxo, Rubella, CMV and HSV 1/2 tests; the results show that the ToRCH IgM Combo Rapid Test Cassette has a high sensitivity and specificity for each of its sections.

TOXO

Relative Sensitivity: 94.0% (95%CI*: 83.5%-98.7%) *Confidence Interval
Relative Specificity: 98.8% (95%CI*: 97.1%-99.6%)
Accuracy: 98.2% (95%CI*: 96.5%-99.2%)

Rubella

Relative Sensitivity: 93.4% (95%CI*: 89.4%-99.9%) *Confidence Interval
Relative Specificity: 99.0% (95%CI*: 97.2%-99.8%)
Overall Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

CMV

Relative Sensitivity: 92.3% (95%CI*: 79.1%-98.4%) *Confidence Interval
Relative Specificity: 98.8% (95%CI*: 96.9%-99.7%)
Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

HSV 1/2

Relative Sensitivity: 91.4% (95%CI*: 76.9%-98.2%) *Confidence Interval
Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%)
Accuracy: 97.9% (95%CI*: 95.8%-99.2%)