PEPFAR Field Advisory on Recall of Certain HIV Rapid Test Kits


January 5, 2012

 PEPFAR Field Advisory on Recall of Certain HIV Rapid Test Kits

As of December 20, 2011, PEPFAR advised its country teams to quarantine all Standard Diagnostics (SD) Bioline 1/2 3.0 HIV rapid test kits procured with PEPFAR funds through the Supply Chain Management System (SCMS) or any other U.S. Government partner. In addition, these SD Bioline kits have been removed from the USAID list of approved rapid HIV test kits and can no longer be procured with PEPFAR funds. SD has issued recall notices (below) for certain lots of these test kits; however, PEPFAR has advised countries using this product to immediately quarantine all SD Bioline 1/2 3.0 HIV rapid test kits, regardless of lot number.

The de-listing of this product is the result of quality assurance testing policies of PEPFAR and is consistent with World Health Organization (WHO) recommendations. Recent quality assurance evaluations identified defective kits with substantial red background color in the test window where results are read. The background color can prevent reading of the results leading to an "invalid" test result. No confirmed false-positive or false-negative results have been identified.

Rapid HIV test kits have been demonstrated to be an effective diagnostic tool essential to HIV/AIDS programs. The removal of the SD Bioline HIV 1/2 3.0 test from the USAID list of approved test kits reflects PEPFAR’s commitment to support the highest quality diagnostics and drugs in its programs. The vigilance of quality assurance processes implemented for PEPFAR programs helps ensure that rapid test kits are accurate and meet minimum quality standards. PEPFAR is working with each country affected by the recall to ensure there are no interruptions in testing or to minimize interruptions by identifying alternative testing strategies. Additionally, PEPFAR is mobilizing to place immediate orders of rapid test kits from approved manufacturers to serve as bridging stocks while country-specific HIV testing strategies are developed and implemented.

For further information: Update on SD Bioline recall by the World Health Organization:

http://www.who.int/diagnostics_laboratory/procurement/120106_final_update_info_sd_bioline_hiv_rtd.pdf

Field safety notice issued by the World Health Organization:

http://www.who.int/diagnostics_laboratory/procurement/111201_productalert_for_product0027_mx012.pdf

Current USAID list of approved rapid test kits:

http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/hiv_tests.pdf

PEPFAR Contact:

Kate Glantz

glantzke@state.gov

202-663-2952

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