ALLTEST HIV 1.2 Professional Rapid Test Cassette (Whole Blood/Serum/Plasma) IHI-402

Human Immunodeficiency Viruses Rapid Testing Kit 

Professional HIV-1 & HIV-2 Antibody Rapid Test | >99.9% Accuracy

The HIV 1.2 Rapid Test Cassette is a CE-marked, in vitro diagnostic (IVD) rapid immunoassay designed for the qualitative detection of antibodies to Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2).
It delivers fast, reliable results in just 10 minutes using whole blood, serum, or plasma, making it ideal for clinical, laboratory, screening, and professional healthcare settings.

This is a professional end-use rapid test kit, and is NOT intended for self/home use.

Key Features & Benefits

• Detects HIV-1 and HIV-2 antibodies
• Works with multiple specimen types:
  Whole blood (venipuncture or fingerstick), serum, or plasma
• Fast results: Read in 10 minutes
• Exceptional clinical performance: (Sensitivity: >99.9%, Specificity: 99.9%, Overall accuracy: 99.9%)
• CE certified (CE 2934) – compliant with European IVD standards
• No instrumentation required
• Simple cassette format for easy handling
• High precision and reproducibility (>99% intra- and inter-assay precision)

Clinical Accuracy You Can Trust

The HIV 1.2 Rapid Test Cassette has been extensively evaluated against leading EIA and CMIA laboratory assays, demonstrating 99.9% correlation.

Performance Highlights

• Relative sensitivity: 99.8% (95% CI: 99.0% – >99.9%)
• Relative specificity: 100% (95% CI: 99.8% – 100%)
• Accuracy: 99.9%

Validated on:

• HIV-1
• HIV-2
• Multiple HIV subtypes
• Blood donors
• Pregnant women
• Clinically negative specimens

No cross-reactivity was observed with hepatitis markers, syphilis, EBV, CMV, HSV, H. pylori, tumour markers, or common interfering substances.

How the Test Works

This test uses a membrane-based chromatographic immunoassay:

• Recombinant HIV antigens are pre-coated on the membrane
• HIV antibodies (if present) bind to antigen-coated particles
• A visible test line (T) indicates a positive result
• A control line (C) confirms correct test performance

Results interpretation:

• Positive: Two colored lines (C + T)
• Negative: One colored line (C only)
• Invalid: No control line

Intended Use

• Professional in vitro diagnostic use only
• For screening and aid in diagnosis of HIV infection

Suitable for:

• Hospitals
• Clinics
• Diagnostic laboratories
• Public health programs
• Medical screening services

This test detects HIV antibodies and should be interpreted alongside clinical findings and confirmatory testing.

Specifications

• Product Name: HIV 1.2 Rapid Test Cassette
• Specimen Types: Whole blood, serum, plasma
• Result Time: 10 minutes
• Storage Conditions: 2–30 °C (do not freeze)
• Shelf Life: Until expiration date on pouch
• Method: Rapid chromatographic immunoassay
• Certification: CE 2934
• Use: Single-use only

What’s Included

• 40 x HIV 1.2 Rapid Test Cassettes
• 2 x Buffer solution
  
• Instructions for use

(Optional accessories such as lancets and droppers may be added depending on the version purchased)