The findings and conclusions in these presentations have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.

Tuesday, March 11, 2008
P85

Indicators Related to Chlamydia trachomatis Testing in Region I Infertility Prevention Project Public Health Laboratories

Gary E. Budnick1, Alan Borne2, Eunice Froeliger3, Harvey George2, Linda Han2, Kenneth Jones4, Sue Macrae5, Kenneth Pote6, and Region I. IPP Advisory Committee7. (1) Connecticut Dept. of Public Health Laboratory, 10 Clinton Street, Hartford, CT, USA, (2) State Laboratory Institute, Massachusetts Department of Public Health, Boston, MA, USA, (3) Vermont Department of Health Laboratory, Burlington, VT, USA, (4) Rhode Island Department of Health, Providence, RI, USA, (5) Public Health Laboratories, NH DHHS Division of Public Health Services, Concord, NH, USA, (6) Department of Health and Human Services, State of Maine, Augusta, ME, USA, (7) Region I IPP, Hartford, CT, USA


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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