HIV-1/2 Antibodies and HIV-1 p24 Antigen Combo Tests 25/Box

Rapid Point-of-Care 4th Generation HIV Test for Fingerstick Whole Blood by Abbott Rapid DX North America.

The Abbott HIV-1/2 Antibodies and HIV-1 p24 Antigen Combo Test is the first FDA-approved, rapid point-of-care test to detect both HIV-1/2 antibodies and free HIV-1 p24 antigen. Utilizing advanced 4th generation technology, this lateral flow immunoassay enables healthcare professionals to diagnose acute and established HIV infection earlier than ever—often before antibody-only tests (2nd and 3rd generation) can provide a positive result. This 25-test kit is specially designed for fingerstick whole blood, empowering clinics, outreach programs, urgent care settings, and community health initiatives to provide fast, reliable, and accessible HIV screening.

What It Is Used For

• Early detection of HIV-1 and HIV-2 infection in adults or children by identifying both antibodies and the HIV-1 p24 antigen.
• Point-of-care testing in clinics, emergency settings, mobile units, or community health centers.
• Screening high-risk individuals who may have been recently exposed to HIV, enabling earlier intervention and linkage to care.
• Confirmatory follow-up for clients with potential recent HIV exposures when acute HIV infection is suspected.

Details and Features

• First FDA-cleared 4th generation rapid HIV test: Detects acute (antigen) and established (antibody) infections.
• Lateral Flow Immunoassay: Simple fingerstick sample collection—no laboratory infrastructure required.
• Time to results: As fast as 20 minutes; results valid for up to 30 minutes after starting test.
• Distinct Test Lines: Clearly distinguishes between HIV-1 p24 antigen and HIV-1/2 antibodies.
• Broad Storage Range: Store between 2-30°C (36-86°F) for convenient on-site and off-site deployment.
• Long Shelf Life: 24 months* for test kits, 24 months** for external controls.
• High Sensitivity & Specificity:
  • Fingerstick Whole Blood: Sensitivity 99.9%, Specificity 99.8%
  • Venous Whole Blood: Sensitivity 99.9%, Specificity 99.7%
  • Serum: Sensitivity 99.9%, Specificity 99.6%
  • Plasma: Sensitivity 99.9%, Specificity 99.7%
• Works with multiple sample types: Fingerstick whole blood, venous blood, serum, or plasma.
• Operating temperature: 15-30°C (59-86°F)—ideal for field and clinic use.

Dosage (Testing Volume)

• Sample requirement: Only one drop (usually 50 μL) of fingerstick whole blood, venous blood, serum, or plasma per test.

CDC Guidelines

• CDC recommends routine HIV screening for all individuals aged 13–64 at least once, and annual testing for high-risk groups.
• 4th generation antigen/antibody tests are now preferred for initial HIV screening because they reliably detect early (acute) HIV infection before antibody tests alone.
• Point-of-care rapid tests facilitate same-day risk reduction counseling, immediate medical linkage, and timely care for those who test positive.

Mechanism of Action

This lateral flow immunochromatographic assay detects:

• HIV-1 p24 antigen: Produced in early acute infection, prior to antibody formation.
• HIV-1/2 antibodies: Appear later following infection.

Upon sample addition, HIV-1 p24 antigen or HIV-1/2 antibodies bind to specific, labeled antibodies embedded in the test strip. A visible line appears in the corresponding test window if the sample is reactive, providing clear, rapid, and accurate visual results.

Directions

1. Allow test and sample to reach room temperature (if refrigerated).
2. Prepare the fingerstick sample using aseptic technique.
3. Add the correct amount of blood/serum/plasma to the sample well as per kit instructions.
4. Add buffer (if required by the procedure) to the buffer well.
5. Start the timer: Read results at 20 minutes; do not interpret after 30 minutes.
6. Interpret results: Refer to included visual guide. Control line must appear for the test to be valid.
7. Dispose of all materials as biohazardous waste according to local regulations.

Warnings

• For in vitro diagnostic use only. Not for use in screening blood donors.
• Read results only within 20-30 minutes. Results interpreted after this window may be inaccurate.
• False negatives may occur in early infection, immunodeficient patients, or if procedures aren’t followed precisely.
• Positive results should be confirmed with additional approved HIV diagnostic testing per CDC recommendations.
• Wear gloves and use standard precautions—handle all blood samples as potentially infectious.
• Do not use expired kits, damaged packaging, or improperly stored tests.
• Highly sensitive: Cross-contamination between specimens or improper sample handling may yield inaccurate results.

Side Effects

• None to the patient: This test is non-invasive except for fingerstick, which may cause minor, brief discomfort, redness, or bruising.
• Psychosocial impact: Positive or indeterminate results can cause distress; provide appropriate pre- and post-test counseling.

The Abbott HIV-1/2 Antibodies and HIV-1 p24 Antigen Combo Test empowers healthcare providers with the speed and sensitivity to identify HIV earlier, link individuals to care swiftly, and help prevent further transmission. Clinically proven, FDA-cleared, and designed for maximum accuracy—make rapid, reliable HIV testing accessible and efficient in your setting.