ToRCH Rapid Test

ToRCH Rapid Test

PocTell® 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.

Product Introduction

INTENDED USE

 

PocTell® ToRCH Rapid Test 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 human whole blood, serum or plasma.
For professional in vitro diagnostic use only.
PocTell® 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.

 

ToRCH Rapid Test P

 

Ordering Information

 

Test Item

Format

Specimen

Reaction Time

Shelf life

Kit Size

ToRCH

Cassette

WB / S / P

10 mins

24 months

25T/Kit

 

TEST PRINCIPLE

 

ToRCH Rapid Test Device chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxo, Rubella, CMV, and HSV1/2 in whole blood, Serum or Plasma. Each test consists of: 1) a burgundy colored conjugate pad containing TORCH recombinant envelope antigens conjugated with Colloid gold (TORCH conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-TORCH, T2 band is coated with antibody for the detection of IgG anti-TORCH, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-TORCH, if present in the specimen, will bind to the TORCH conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a TORCH IgG positive test result and suggesting a recent or repeat infection. IgM anti-TORCH if present in the specimen will bind to the TORCH conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a TORCH IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

 

36020250617135728

 

DIRECTIONS FOR USE

 

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2.Transfer a drop of Whole Blood/Serum/Plasma (approximately 10μl) to the specimen well of the device with a dropper provided in the kit and add 2-3 drops of buffer(approximately 80μl-120μl) then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
3.Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

 

ToRCH Rapid Test Steps

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