multiple cassette ToRCH IgG/IgM Combo Rapid Test device ,gold colloidal method,Blood/serum/plasma

Product Name: One Step ToRCH IgG/IgM Combo Rapid Diagnostic Test Cassette

Intended Use:

ToRCH IgG/IgM Combo Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies and 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 IgG/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

The ToRCH IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to Toxoplasma, Rubella, CMV and HSV 1/2 in whole blood, serum or plasma specimens. In this test, mouse anti-human IgG and 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 Toxoplasma antigen, Rubella antigen, CMV antigen and HSV 1/2 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 IgG or mouse anti-human IgM on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for Toxoplasma, Rubella, CMV or HSV 1/2 infection, while its absence indicates a negative result for that infection.To serve as a procedural control, a colored line will always appear in the control line region of the strip 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 IgG/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 IgG/IgM Combo Rapid Test Cassette has a high sensitivity and specificity for each of its sections.

TOXO IgG

Relative Sensitivity: 96.0% (95%CI*: 86.3%-99.5%) *Confidence Interval

Relative Specificity: 98.5% (95%CI*: 96.8%-99.4%)

Accuracy: 98.2% (95%CI*: 96.5%-99.2%)

TOXO IgM

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 IgG

Relative Sensitivity: 91.8% (95%CI*: 81.9%-97.3%) *Confidence Interval

Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%)

Overall Accuracy: 97.6% (95%CI*: 95.4%-98.9%)

Rubella IgM

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 IgG

Relative Sensitivity: 93.5% (95%CI*: 82.1%-98.6%) *Confidence Interval

Relative Specificity: 98.8% (95%CI*: 96.9%-99.7%)

Accuracy: 98.1% (95%CI*: 96.2%-99.2%)

CMV IgM

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 IgG

Relative Sensitivity: 94.3% (95%CI*: 80.8%-99.3%) *Confidence Interval

Relative Specificity: 98.4% (95%CI*: 96.2%-99.5%)

Accuracy: 97.9% (95%CI*: 95.8%-99.2%)

HSV 1/2 IgM

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%)

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.