Herpes test kit

rubellafor toxoplasmosisfor TORCH infections

Description
The ToRCH IgM Antibodies Combo Rapid Test Cassette is a qualitative lateral-flow chromatographic immunoassay for in vitro detection of IgM antibodies to Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV) and Herpes simplex virus 1/2 (HSV 1/2) in serum, plasma or whole blood. It is intended to support clinical diagnosis of recent ToRCH infections.

Specimen collection

• 1. The test can be performed on serum, plasma or whole blood.
• 2. Collect specimens following standard clinical laboratory procedures.
• 3. Separate serum or plasma from cells promptly to avoid hemolysis; use only clear, non-hemolyzed specimens.
• 4. Test specimens as soon as possible. Store serum/plasma at 2–8℃ for up to 3 days; for long-term storage keep below -20℃.
• 5. Bring specimens to room temperature prior to testing. Thaw frozen specimens completely and mix; avoid repeated freeze–thaw cycles.

Operating Steps

• Allow test device, specimen, buffer and controls to reach room temperature (15–30℃) before use.
• 1. Bring the pouch to room temperature, open and remove the device; use immediately.
• 2. Place the device on a clean, level surface.
• 3. Hold the dropper vertically and add 1 drop of specimen (approx. 10 μl) into the specimen well, then add 2 drops of buffer (approx. 80 μl) and start the timer.
• 4. Wait for colored line(s) to appear. Read results at 15 minutes; do not interpret after 20 minutes.

Performance and product information

• Product name: ToRCH IgM Antibodies Combo Rapid Test
• Specimen: Whole Blood, Serum, Plasma
• Method: Colloidal gold lateral-flow chromatographic immunoassay
• Form: In vitro diagnostic rapid test cassette
• Reading time: read at 10–15 minutes (interpret at 15 minutes; do not read after 20 minutes)
• Accuracy: approximately 98%
• Certification: ISO9001, ISO13485
• Shelf life: 24 months
• Package: 25 tests per box

Technical specifications

• Specimen types: Whole blood, serum, plasma
• Assay principle: Colloidal gold immune chromatographic assay
• Format: Strip or cassette (rapid test cassette)
• Sample volume: ~10 μl per test; buffer ~80 μl
• Incubation/reading: Read at 15 minutes; do not interpret after 20 minutes
• Storage conditions: 2–30℃ (follow label); long-term storage below -20℃
• Shelf life: 24 months
• Packing: 25 tests/box