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Richard Steece, Ph.D., D(ABMM) DrRSteece@aol

CDC National Infertility Prevention Project Laboratory Update Region V February 3-4, 2009 Chicago, Illinois. Richard Steece, Ph.D., D(ABMM) DrRSteece@aol.com. 1. Laboratory Guidelines Summary 2. Alternate Specimen Bank.

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Richard Steece, Ph.D., D(ABMM) DrRSteece@aol

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  1. CDC National Infertility Prevention ProjectLaboratory UpdateRegion VFebruary 3-4, 2009Chicago, Illinois Richard Steece, Ph.D., D(ABMM) DrRSteece@aol.com

  2. 1. Laboratory Guidelines Summary2. Alternate Specimen Bank

  3. Expert Consultation Meeting Summary Report January 13‐15, 2009, Atlanta, GA CDC/APHL Guidelines for Testing of Chlamydia and Gonorrheahttp://www.aphl.org/aphlprograms/infectious/std/Pages/stdtestingguidelines.aspx APHL/CDC Panel Summary Reports: The target audience for these recommendations includes laboratory directors, laboratory staff, clinicians and disease control personnel.

  4. Summary of Major Conclusions: Nucleic acid amplification tests (NAATs) are recommended for detection of reproductive tract infections caused by C. trachomatis and N. gonorrhoeae infections in men and women with and without symptoms. Optimal specimen types for NAATs are first catch urine from men and vaginal swabs from women.

  5. Summary of Major Conclusions: NAATs are recommended for the detection of rectal and oropharyngeal infections caused by C. trachomatis and N. gonorrhoeae. However, these specimen types have not been cleared by the FDA for use with NAATs and laboratories must establish performance specifications to satisfy CMS regulations for CLIA compliance prior to reporting results for patient management. (493.1253(b)(2))

  6. Summary of Major Conclusions: Routine repeat testing of NAAT positive screening specimens is not recommended.

  7. Alternate Specimen Bank 1. Rectal (pharyngeal to follow) 2. Gen-Probe (BD to follow) e-mail Carol Farshy at cef1@cdc.gov CLIA Checklist: APHL.ORG

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