The purpose of this message is to address issues raised as a result of the CDC Dear Colleague letter from Dr. Kevin Fenton, Director, CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, dated August 16, 2010 and distributed on August 18, 2010.

The letter from Dr. Fenton conveyed CDC concerns regarding the reporting practices adopted by some laboratories using commercially available chlamydia and gonorrhea nucleic acid amplification tests when low positive specimens were routinely retested.  The letter requested that Laboratory Directors review their procedures and affirm appropriate reporting of disparate test results by following manufacturers’ instructions and the most recent guidance provided by CDC (2002).  Furthermore, laboratories were advised to notify their users of any results from the past two years that were reported as “negative” after routine retesting under conditions highlighted by the letter.

The Question and Answer document, linked here, developed in consultation with the Association of Public Health Laboratories (APHL), the Food and Drug Administration (FDA), and the Centers for Medicaid & Medicare Services (CMS), is intended to clarify the intent of the letter distributed in August and the actions Laboratory Directors should take when interpreting and reporting results of these nucleic acid amplification tests for chlamydia and gonorrhea.