Infectious disease test kit

IgGIgMserum

Overview The Filariasis IgG/IgM Combo Rapid Test is a lateral flow immunoassay for simultaneous detection and differentiation of IgG and IgM antibodies against lymphatic filarial parasites (Wuchereria bancrofti and Brugia malayi) in human serum, plasma or whole blood. It is intended for screening and as an aid in diagnosis. Reactive specimens must be confirmed with alternative methods.

Product Details

• Product name: Filariasis IgG/IgM Combo Rapid Test cassette (POCT)
• Specimens: Whole blood, plasma, serum
• Method: Colloidal gold immunochromatographic assay
• Form: In vitro diagnostic rapid test cassette
• Reading time: read at 10 minutes; do not interpret after 20 minutes
• Accuracy: approximately 98%
• Format: Strip or cassette
• Certification: ISO9001, ISO13485
• Shelf life: 24 months
• Package: 25 tests per box

Intended use The test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial antibodies (W. bancrofti and B. malayi) in human serum, plasma or whole blood. It is intended as a screening tool and as an aid in clinical diagnosis. Any reactive result should be confirmed by alternative laboratory methods.

Operating Steps

• Allow device, specimen, buffer, and controls to equilibrate to room temperature (15–30°C) before testing.
• Open foil pouch and use the device promptly (best within one hour).
• Place device on a clean, level surface. Transfer specimen using a pipette or disposable dropper:
  • Using a pipette: add 5 µL whole blood to the specimen well, then add 3 drops of buffer (~180 µL) and start timer.
  • Using a disposable dropper: draw specimen to the fill line (~5 µL), dispense into specimen well, then add 3 drops of buffer (~180 µL) and start timer.
• Wait for colored line(s) to appear. Read result at 10 minutes. Do not interpret after 20 minutes.

Technical specifications

• Product: Filariasis IgG/IgM Combo Rapid Test cassette
• Specimen types: Whole blood / Plasma / Serum
• Method: Colloidal gold immunochromatographic assay
• Form: In vitro diagnostic rapid test cassette
• Reading time: read at 10 minutes; do not interpret after 20 minutes
• Accuracy: ~98%
• Format: Strip or cassette
• Certification: ISO9001, ISO13485
• Shelf life: 24 months
• Package size: 25 tests/box