Abstract: Indicators Related to Chlamydia trachomatis Testing in Region I Infertility Prevention Project Public Health Laboratories (2008 National STD Prevention Conference)

Tuesday, March 11, 2008

Continental Ballroom

Gary E. Budnick , Connecticut Dept. of Public Health Laboratory, Hartford, CT

Alan Borne , State Laboratory Institute, Massachusetts Department of Public Health, Boston, MA

Eunice Froeliger , Vermont Department of Health Laboratory, Burlington, VT

Harvey George , State Laboratory Institute, Massachusetts Department of Public Health, Boston, MA

Linda Han, MD, MPH , State Laboratory Institute, Massachusetts Department of Public Health, Boston, MA

Kenneth Jones , Rhode Island Department of Health, Providence, RI

Sue Macrae , Public Health Laboratories, NH DHHS Division of Public Health Services, Concord, NH

Kenneth Pote , Department of Health and Human Services, State of Maine, Augusta, ME

Region I. IPP Advisory Committee , Region I IPP, Hartford, CT

Background:
From 2004-2007, Region I Infertility Prevention Project (IPP) public health laboratories (PHLS) have demonstrated a region wide positive reproducibility rate exceeding 94% using nucleic acid amplification test (NAAT) Chlamydia trachomatis (CT) testing technologies. PHLS have achieved and maintained testing and specimen transit turnaround time (TAT) levels based on established regional objectives.

Objective:
Describe and evaluate precision, specimen holding time and laboratory testing TAT studies conducted by Region I IPP PHLS.

Method:
Annual studies were undertaken to evaluate progress toward two priority objectives; “ensuring minimal standards for additional testing on all positive specimens” and to “improve appropriate and timely treatment.” Each PHL determined assay reproducibility rates for least 100 initial NAAT positive specimens. Data was complied and assessed for consistency with manufacturer's validation. Two additional time related studies, specimen transit TAT and testing TAT, were performed for a one-week period. Data was collated and analyzed for each laboratory and regionally by specimen type and testing technology.

Result:
Overall region-wide average reproducibility of 3253 initial positive CT test results from urine, endocervical and urethral swabs was 94.7% (88-100%); 93.6% for PHLS using BD Probetec; 96.6% for PHLS using Genprobe Aptima 2 Combo. Results for 99.3% (95.9-100%) of 10662 specimens were reported within 3 working days of receipt in the laboratory. Of the approximately 11200 specimens tracked from collection to receipt in the PHL, 96.8% (88.8-100%) were received within the established goal.

Conclusion:
Reproducibility rates are consistent with manufacturers validation data and provide evidence for consideration of eliminating repeat testing on initial positive specimens. Region I IIP PHLS are meeting established goals for specimen holding and reporting TAT's.

Implications:
Addressing issues of specimen quality and handling, analyst competency and differences in technology can guide recommendations for improvement.

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