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, May 9, 2006

Rapid Development of Local Laboratory Capacity for LGV Diagnosis: The New York Experience

Preeti Pathela1, Jennifer Baumgartner1, Susan Blank2, Lillian Lee3, John Papp4, Angelica O'Connor4, Ronald Limberger5, and Julia A. Schillinger2. (1) STD Control, New York City Department of Health & Mental Hygiene, 125 Worth Street, Room 207, CN 73, New York, NY, USA, (2) Bureau of Sexually Transmitted Disease Control, NYC DOHMH / Division of STD Prevention, CDC, 125 Worth St., Room 207, CN-73, New York, NY, USA, (3) PHL, New York City Department of Health and Mental Hygiene, New York, NY, USA, (4) Division of STD Prevention, Centers for Disease Control, Atlanta, GA, USA, (5) Wadsworth Center, New York State Department of Health, Albany, NY, USA

Lymphogranuloma venereum (LGV) was recognized as a cause of proctocolitis in New York City (NYC) in early 2005. The NYC Public Health Laboratory (PHL) had not validated performance of Chlamydia trachomatis (Ct) nucleic acid amplification tests (NAATs) for anorectal specimens, which were referred to the CDC's Ct reference laboratory for Ct assessment and, if positive, LGV differentiation. Continued LGV detection highlighted the need to expand local diagnostic services and lessen reliance on reference testing.

To describe development of local laboratory capacity for LGV and resulting findings.

To advance local diagnostic testing capacity, the New York State PHL (Wadsworth) verified the performance of an existing Ct NAAT for use on anorectal swabs. An L-2 specific NAAT primer targeting the omp1 gene was developed. Ct and L-2 specific primers are now multiplexed on a real-time PCR platform allowing simultaneous screening of anorectal specimens for Ct and its L-2 serovar. Ct-positive/L-2-negative specimens are sent for direct omp1 gene sequencing.

Of 132 male anorectal specimens received from possible LGV case-patients, 43 (33%) were Ct-positive, and 66% (23/35) of those sequenced were LGV-positive (all L-2). Specimen handling of anorectal swabs is simple (stored dry, room temperature), however shipping from NYC PHL to Wadsworth is costly and adds to turnaround time; specimen collection to return of result to physician averages 11 days.

Among males tested for LGV in NYC, one-third of proctitis is due to Ct infection, both LGV and non-LGV. Development of Ct/L-2 primers by Wadsworth was invaluable. Even if NYC PHL capacity for LGV diagnosis is not developed, validation of anorectal Ct NAATs would aid in even more timely Ct diagnosis and reduce numbers of specimens sent to Wadsworth.

When timeliness of disease intervention is affected, local rather than national reference diagnostic testing facilities should be utilized, if possible.