Description:

HIV One Step Rapid Test by Hightop (manufactured by Qingdao Hightop Biotech Co., Ltd.) is an immunochromatographic lateral flow assay designed for the qualitative detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum, or plasma. It serves as a screening tool to aid in the diagnosis of HIV infection, providing results in approximately 15 minutes. It is a one-step rapid test based on direct binding principles for point-of-care or laboratory use.

Prescription:

• No (over-the-counter or professional use diagnostic kit, but professional interpretation and confirmatory testing are required)

Therapeutic Category:

• In Vitro Diagnostic (IVD) Device / Rapid Immunochromatographic Test / HIV Antibody Screening Test

Active Ingredients/Composition:

• Contains HIV-1/2 recombinant antigens (gp41, gp120, gp36) conjugated to colloidal gold particles, immobilized on a nitrocellulose membrane test strip/cassette (no active pharmaceutical ingredients; diagnostic reagents only)

Variant:

• Cassette (most common), strip formats available (e.g., 2.5mm/3.0mm/3.5mm width); may include HIV 1/2 Ab, HIV Ag/Ab combo, or tri-line versions in some listings

Consume Type:

• In Vitro Diagnostic (sample-based test: whole blood, serum, or plasma)

Directions/Usage:

• Collect sample (fingerstick whole blood ~10-50 µL, or serum/plasma). Add sample to the sample well on the cassette/strip, then add 1-2 drops of buffer/chase solution. Read results after 15 minutes (do not read after 30 minutes). Appearance of a test line (T) with control line (C) indicates positive; only control line indicates negative. Follow package insert precisely. Must be used by trained personnel or under guidance; positive results require confirmatory testing (e.g., Western blot, PCR).

Common Side Effects:

• None (diagnostic test, not a therapeutic product). Potential issues include false positives/negatives, but no direct side effects on the user from the test itself.

Package Type:

• Individual foil pouches containing test cassette/strip, desiccant, dropper/pipette, and buffer; typically in kits of 25, 40, or 50 tests per box

Storage Advice:

• Store at 2-30°C (36-86°F) in a dry place, protected from direct sunlight and moisture. Do not freeze. Shelf life usually 24 months from manufacture date. Use within the specified time after opening pouch.

Safety Advice:

• For in vitro diagnostic use only. Not for self-testing in all regions (professional use recommended). Positive results must be confirmed by laboratory methods. Handle blood samples as potentially infectious; use gloves and proper disposal. Do not use expired kits or if pouch is damaged. Not reliable in window period (early infection). Consult healthcare provider for interpretation and follow-up. In some countries (e.g., UK), certain Hightop versions were flagged for reliability issues and lack of valid CE marking—verify local regulatory approval before use.

Product Substitutes:

• Determine HIV-1/2 (Abbott)
• OraQuick Advance HIV-1/2 (OraSure)
• Rapid Response HIV 1/2 Test Cassette (BTNX)
• Bioline HIV-1/2 3.0 (Abbott)
• Wondfo One Step HIV 1/2 Test
• Other WHO-prequalified HIV rapid tests (e.g., from InTec, Chembio)

Manufacturer/Marketer:

• Qingdao Hightop Biotech Co., Ltd.

Country of Origin:

• China