Laboratory Verification of NAATs for GC/CT in non-FDA Cleared Specimens

Technical Assistance Monograph coming soon.
 

Relevant Literature and Other Resources

1)“Practical Guidelines for Chlamydia Test Verification, National Chlamydia Laboratory Committee (June, 1999; revised March, 2001). Practical Guidelines for CT Test Verification (PDF)

2) “Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule” (Federal Register, vol. 68, no. 16, January 24, 2003). Medicare Medicaid and CLIA Fed Reg (PDF)

3) Renault CA, Hall C, Kent CK, Klausner JD. “Use of NAATs for STD diagnosis of GC and CT in non-FDA-cleared anatomic specimens.” MLO. 2006 July;10-15,21-22.

4) Kent CK, Chaw JK, Wong W, Liska S, Gibson S, Hubbard G, Klausner JD. “Prevalence of Rectal, Urethral, and Pharyngeal Chlamydia and Gonorrhea Detected in 2 Clinical Settings among Men Who Have Sex with Men: San Francisco, 2003.” Clin Inf Dis. 2005;41:000-000.

5) BD Symposium Presentations. Jacksonville, FL. May 9, 2006.
  • Bachmann, Laura H. “Performance Of Nucleic Acid Amplification Tests (NAATs) To Detect Rectal And Pharyngeal Gonococcal And Chlamydial Infection.”
  • Kent, Charlotte. “Prevalence of Rectal & Pharyngeal Chlamydia & Gonorrhea in Men Who Have Sex with Men: San Francisco.”
  • Hall, Christopher. “Expansion of NAATs for the Detection of Non-genital Chlamydia/Gonorrhea Infections in California.”
  • Steece, Richard. “Regulatory Restrictions for FDA Modified or Off-Label Testing.”

    BD Lunch Presentation STD Meeting v1 May 9 2006. (PPT)

6) Elder BL, Hansen SA, Kellogg JA, Marsik FJ, and Zabransky RJ. “Verification and Validation of Procedures in the Clinical Microbiology Laboratory.” Cumitech 31. American Society for Microbiology. Feb 1997.

 

Laboratories conducting verified non-genital NAAT testing

Some commercial laboratories (e.g., Labcorp, Quest Diagnostics) will process non-genital NAATs for gonorrhea and chlamydia. 

For more information on ordering these tests, click here.

Contact your commercial lab provider for the most up-to-date information.


Contacts for further information

Christopher S. Hall, MD, MS
(Technical assistance; can direct to other California-specific resources)
Chief – Office of Clinical Affairs
California STD Control Branch
300 Frank H. Ogawa Plaza, Suite 520
Oakland, CA 94612-2032
voice: 510-625-6006
fax: 510-836-0239

Sally Liska, DrPH
San Francisco Public Health Laboratory
101 Grove Street, Room 419
San Francisco, CA 94102
(415) 554-2800
Sally.Liska@sfdph.org

Sheldon Morris MD MPH
Medical Epidemiologist
UCSD Antiviral Research Center
150 West Washington St.
San Diego, CA 92103
(619) 543-8080
shmorris@ucsd.edu

John Papp, PhD
Chlamydia Laboratory
Centers for Disease Control and Prevention
Data and Specimen Handling Activity (DASH), Unit 32
BLDG 4, RM B35—G12
1600 Clifton Road NE
Atlanta, GA 30333
(404) 639-3785
JPapp@cdc.gov

Richard Steece, Ph.D., D(ABMM)
National Chlamydia Laboratory Coordinator
CDC National Infertility Prevention Project
1811 Flag Mountain Drive
Pierre, South Dakota 57501
(605) 224-9240
DrRSteece@aol.com

Technical assistance monograph for clinicians and program directors

© 2007, California STD/HIV Prevention Training Center  E-Mail: CAPTC@CDPH.ca.gov  (510)-625-6000
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