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

Low False Recency Rate

False recency rate comparable to the Sedia ® HIV-1 Limiting Antigen (LAg)-Avidity EIA laboratory assay.*

*Parek B, Detorio M, Shanmugam V, et al. Performance evaluation of Asanté ® HIV-1 Rapid Recency Assay for HIV diagnosis and detection of recent infection: Potential for surveillance and prevention. 9th IAS Conference on HIV Science. Paris. 2017. #TUPEC0849

Convenient

No laboratory infrastructure necessary. This enables field testing and collection of recency data in areas that are resource constrained.

Asante-HIV-1-Rapid-Recency-Assay-Kit-2

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.*

*Parek B, Detorio M, Shanmugam V, et al. Performance evaluation of Asanté ® HIV-1 Rapid Recency Assay for HIV diagnosis and detection of recent infection: Potential for surveillance and prevention. 9th IAS Conference on HIV Science. Paris. 2017. #TUPEC0849

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

What type of specimen is required?

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.

The  Asanté ® HIV-1 Rapid Recency ® Assay is for Research Use Only and Not for Use in Diagnostic Procedures. Users of the Asanté ® HIV-1 Rapid Recency® Assay based in the U.S. are required to complete and submit a Certification Regarding Research Use (download here) prior to shipment of the product certifying that use of the product will be used for research use only in compliance with FDA regulations.

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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