Asanté ™ HIV-1 RAPID RECENCY® ASSAY
FOR DISTINGUISHING RECENT VS LONG TERM HIV-1 INFECTIONS IN POSITIVE HIV-1 SPECIMENS
Asanté™ HIV-1 Rapid Recency® Assay
A rapid, 20 minute in vitro immunoassay that differentiates recent from long-term HIV-1 infections for real time surveillance of new HIV-1 infections and the estimation of HIV-1 incidence rates in a population.* The assay can be used with blood (both venous and fingerstick), serum, or plasma specimens as either a laboratory or point-of-collection test.
For Research Use Only: Not for use in diagnostic procedures.
Easy to Use
The Asanté™ HIV-1 Rapid Recency® Assay is faster, more cost effective and simpler to use than conventional HIV-1 incidence lab assays.
Add a loopful of specimen and the Test Strip to the Sample Buffer to begin the assay.
Low False Recency Rate
False recency rate comparable to the Sedia® HIV-1 Limiting Antigen (LAg)-Avidity EIA laboratory assay.*
Convenient
No laboratory infrastructure necessary. This enables field testing and collection of recency data in areas that are resource constrained.
| Catalog Number | Description |
|---|---|
| 1130-020 | Asanté™ HIV-1 Rapid Recency® Assay, 20 Tests, For Research Use Only |
| 1130-100 | Asanté™ HIV-1 Rapid Recency® Assay, 100 Tests, For Research Use Only |
| READER | For additional details regarding the Asanté™ Test Strip Reader contact us today! |
PRODUCT SPECIFICATIONS
| Summary of Specifications | |
|---|---|
| Assay Time | 20 minutes |
| Processing Temperature | 15° to 37°C (59° to 98.6°F) |
| Storage Temperature | 2° to 30°C (35.6° to 86°F) |
| Specimen Type | Human whole blood, plasma (in EDTA or ACD anticoagulants), or serum |
| Specimen Volume | One loopful or 5 µL if using pipette |
| Result Line 1 | Control; ensures proper functioning of the test |
| Result Line 2 | Verification; ensures exclusion of HIV negative specimens |
| Result Line 3 | LT/R; differentiates recent from long term infection |
| Custom Antigen | Custom, multi-clade CDC “rIDR-M” HIV-1 gp41 antigen that provides for reduced HIV-1 subtype bias |
| Mean Duration of Recent Infection | Approximately 180 days* |
| U.S. CDC Qualified | Each lot is performance tested by the U.S. Centers for Disease Control prior to market release |
| Tests per Kit | Available in configurations of 20 tests or 100 tests per kit |
| For Research Use Only | Not for use in diagnostic procedures, RUO products are not to be used for diagnostic purposes, patient management, clinical purposes, or for investigational use within the U.S. |
U.S. CDC Tested
Each Asanté™ HIV-1 Rapid Recency® Assay lot is performance tested by both Sedia’s Quality Control Department and by the U.S. Centers for Disease Control prior to market release.
Certification of CDC testing can be provided upon request.
Contains Three Reaction Lines
Control line indicates the specimen was properly added and the test functioned properly.
Verification line ensures HIV-negative specimens are excluded.
LT/R line differentiates recent from long-term specimens.
Custom Antigen
The assay incorporates a custom multi-clade CDC “rIDR-M” HIV-1 gp41 antigen that provides for reduced HIV-1 subtype bias. Mean duration of recent infection approximately 180 days.*
PRODUCT APPLICATIONS
Enable real time surveillance of new HIV-1 infections and inform resource management.
Evaluate the effectiveness of HIV intervention programs.
Identify optimal populations at risk for targeting HIV vaccine clinical trials. Monitor effectiveness of vaccine candidates.
Identify new “hot spots” of infection.
FREQUENTLY ASKED QUESTIONS
The specimen should be whole blood, plasma (EDTA or ACD anticoagulants), or serum collected via fingertip prick or venipuncture.
Previously collected specimen can be used in the Asanté™ HIV-1 Rapid Recency® assay. It is important to ensure that previously collected specimens were stored in the correct conditions.
Previously collected serum and plasma specimens can be stored at 4°-8°C for a maximum of one (1) week (7 consecutive days). Specimens should be stored at -20°C or below for long term storage.
Previously collected whole blood specimens can be stored at 4°-8°C for up to 24 hours before testing and should not be frozen.
The specimen can either be transferred using the provided Specimen Collection Loop or by using a transfer pipette capable of measuring 5 µL.
5 µL of specimen is required for this assay.
- If using the specimen collection loop, 5 µL of blood is collected.
- If transferring previously collected specimen, please use a transfer pipette with a disposable tip capable of transferring 5 µL.
The specimen should come off after initially dipping the Specimen Collection Loop in the Sample Buffer. To make sure it does, swirl the Specimen Collection Loop around in the buffer several times.
Be sure that the Specimen Collection Loop does not touch the sides of the Sample Buffer tube before making contact with the buffer.
All components of the test kit that contacted or could have contacted whole blood, serum, or plasma should be considered as biohazardous wastes. Follow all local and federal guidelines for disposal of biohazardous waste.
The test should be read immediately after 20 minutes have elapsed to avoid getting false positive results.
Yes, however the test does not differentiate between HIV-1 and HIV-2 infections. It is important in areas where HIV-2 is likely to be encountered that HIV-2 specimens be subsequently identified and excluded from test results as they will likely be reported as recent infections regardless of true recency of infection.
The second line, or Verification line, verifies that a specimen is HIV positive. The presence of only the first (Control line) and second line, indicates the infection is considered recent. The presence of the third line, the LT/R line, signifies the specimen is a long-term infection.
If the Control line and the LT/R line are the only lines show up, the test is considered invalid and should be repeated.
Specimens that give invalid results should be re-tested with a new sample aliquot dispensed into a fresh Sample Buffer tube and tested with a new Test Strip. If the re-test still gives an invalid result, a new specimen should be collected and tested. If the result is still invalid after a new specimen is tested, please contact Sedia Customer Service at customerservice@sediabio.com.
The Asanté™ HIV-1 Rapid Recency® kit should be stored in a dry, low humidity environment. It can be stored at a temperature range of +2° to 30°C; avoid storage above 37°C for long periods of time.
Sedia Biosciences is currently collaborating with the Centers for Disease Control and Prevention (CDC) in the development and evaluation of this assay. Availability may be subject to CDC authorization and approval.
Outside of the U.S., please contact us at customerservice@sediabio.com for regulatory or product information for your specific country.
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