Underdiagnosis of Chlamydia trachomatis infection. Diagnostic limitations in patients with low-level infection

To determine limitations in commonly used methods for detection of Chlamydia trachomatis, 601 genitourinary specimens from patients in a sexually transmitted disease clinic were examined with quantitative cultures and by 2 different direct antigen tests, immunofluorescence (Micro Trak; Syva Company, Palo Alto, CA) and enzyme immunoassay (Chlamydiazyme; Abbott Laboratories, North Chicago, IL). Genital specimens were held no longer than 5 hours (at 4 degrees C) prior to inoculation for culture; 28% (168/601) were positive. To evaluate the effect of storage on culture efficacy, duplicate specimens were also stored at -70 degrees C and brought out subsequently for culture a second time. Only 32% (8/25) of specimens cultured within 5 hours and having less than 10 inclusions were positive on reculture, compared with 98% (49/50) positive for specimens with greater than or equal to 10 inclusions initially (P less than 0.001). Sensitivities of the two antigen tests were similar and taken together diminished significantly (P less than 0.001) as the number of organisms (inclusion forming units) in corresponding cultures decreased: 82% (51/62) sensitivity in cultures with greater than 100 inclusions; 50% (22/44) with 10-100 inclusions; and only 11% (6/53) with less than 10. Lack of urethral discharge in men with C. trachomatis infection (free of Neisseria gonorrhoeae) was associated with low numbers of inclusions (less than 10) and antigen tests failed in 68% (15/22) of these patients.