ATFirst™ · Hepatitis and HIV rapid tests
ATFirst™ HIV / HBsAg / HCV Combo Rapid Test
One lateral flow cassette with three test lines for the qualitative detection of HIV 1/2 antibodies, hepatitis B surface antigen (HBsAg) and HCV antibodies in whole blood, serum or plasma. Results are read at 10–20 minutes.
- Professional use
- Three test lines: HIV, HBsAg, HCV
- Result in 10–20 minutes
- Whole blood, serum or plasma
Intended use
The ATFirst™ HIV HBsAg HCV combo rapid test is an immunochromatographic assay for the qualitative detection of HBsAg, HCV antibodies and HIV 1/2 antibodies in human whole blood, serum or plasma. It is intended for professional use as an aid in diagnosing HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) infections.
The assay provides a preliminary result only. According to the insert, all positive specimens should be confirmed with other qualified assays, and a clinician must interpret results together with other clinical and laboratory findings.
First Diagnostic™ Corporation brands and distributes this cassette within its catalog of rapid tests.
Specifications
| Brand | ATFirst™ |
|---|---|
| Catalog number | 85226400555 |
| Format | Cassette with three test lines (T1 HIV, T2 HBsAg, T3 HCV) and a control line |
| Analyte / target | HIV 1/2 antibodies, hepatitis B surface antigen (HBsAg), HCV antibodies |
| Specimen | Whole blood, serum or plasma |
| Sample volume | Whole blood: one drop (40 µl), then two drops (90 µl) of assay buffer. Serum or plasma: two full drops (80 µl). |
| Time to result | Read at 10–20 minutes; confirm negatives at 20 minutes |
| Read window | Do not interpret results after 30 minutes |
| Kit contents | Pouched test cassette with sample dropper and desiccant; sample buffer (2 ml per bottle for 20 tests, for whole blood samples only); instructions for use |
| Storage | Test device in the sealed pouch and buffer bottle at 2–30 °C; do not freeze the test device |
| Intended user | Healthcare professionals |
| Regulatory | Documentation available on request |
| Insert document | Doc No. ATF-555, Version 3, revision November 25, 2015 |
How the HIV HBsAg HCV combo rapid test works
The insert describes a double sandwich immunochromatographic assay. Specific HIV and HCV antigens and monoclonal antibodies against HBsAg are conjugated with colloidal gold on the conjugate pad and are also immobilized on three lines of the nitrocellulose membrane: T1 for HIV, T2 for HBsAg and T3 for HCV.
The sample rehydrates the gold conjugates. HIV 1/2 antibodies, HBsAg or HCV antibodies in the sample bind to them, migrate along the membrane and are captured at the matching line, forming a visible pink line. A pink control band serves as the internal process control. Our guide to lateral flow tests explains the general principle.
Test procedure at a glance
- Prepare the specimen. Collect blood by fingerstick or venipuncture and use only clear, non-hemolyzed specimens. Test whole blood immediately after collection; otherwise the insert allows the blood sample to be stored at 2–8 °C for up to three days and brought to room temperature before use.
- Open the pouch. Tear the sealed pouch at the notch, remove the testing device and place it on a level surface.
- Add the sample. Whole blood: hold the dropper vertically and add one drop (40 µl) to the Sample Well, wait 20–30 seconds, then add two drops (90 µl) of assay buffer to the same well. Serum or plasma: add two full drops (80 µl) of specimen.
- Read the results. Read at 10–20 minutes. Strong positive specimens may give a positive result in as little as 1 minute. Confirm negatives at 20 minutes and do not interpret results after 30 minutes.
This summary does not replace the instructions for use supplied with the kit.
Reading results
- Negative: a pink band appears only at the control region (C).
- Positive: a pink control band (C) and one or more test bands appear. Band T1 indicates HIV positive, band T2 HBsAg positive and band T3 HCV positive.
- Invalid: no band is visible at the control region (C). Repeat with a new test device; if the test still fails, contact your distributor with the lot number.
The control band is an internal quality control. The insert adds that good laboratory practice recommends the daily use of an outside control.
Limitations
- The test is qualitative and gives a preliminary result. All positive specimens should be confirmed with other qualified assays.
- Humidity and temperature can adversely affect results.
- False results can occur because of interfering substances in the specimen or technical and procedural errors.
- Other clinically available tests are required when a result is questionable. A definitive clinical diagnosis should not be based on a single test; it should be made by the physician after all clinical and laboratory findings have been evaluated.
- The insert contains no clinical performance table and states no detection level, so no performance figures are given on this page.
Downloads
The instructions for use supplied with the kit are the reference document for this test.
Frequently asked questions
Which specimens can be tested?
Human whole blood, serum or plasma. The insert states that the anticoagulants heparin, EDTA and citrate do not affect the test result.
How should the kit be stored?
Store the test device in its sealed pouch and the buffer bottle at 2–30 °C. Do not freeze the test device, and keep it away from direct sunlight, moisture and heat.
How many tests are in a kit?
The insert lists one 2 ml bottle of sample buffer, used with whole blood samples only, per 20 tests. Confirm the current pack size on your quotation.
What documentation is available?
The instructions for use (Doc No. ATF-555, Version 3) are listed with our other product inserts and instructions for use. Regulatory documentation is available on request.
How do distributors order?
Complete the distributor application or email sales@firstdiagnostic.com with catalog number 85226400555 and the quantity you need.
Related rapid tests
- Hepatitis and HIV rapid tests — The full category of hepatitis and HIV tests.
- ATFirst™ HBsAg rapid test — Single-analyte cassette for hepatitis B surface antigen in whole blood, serum or plasma.
- ATFirst™ HCV rapid test — Detects antibodies to hepatitis C virus in whole blood, serum or plasma.
- ATFirst™ HIV 1-2-O tri-line rapid test — Antibody test for HIV-1, including group O, and HIV-2 in whole blood, serum or plasma.
- Lateral flow tests explained — How lateral flow tests work and where they are used.
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Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.