BACKGROUND AND OBJECTIVES: More information is needed on the natural history of Chlamydia trachomatis urethral infections in men. Newer assays for detecting antigens in male first void urine and urethral swabs identify patients for control programs. A new microparticle enzyme immunoassay from Abbott Laboratories called IMX Select Chlamydia was evaluated and compared with culture and an expanded gold standard for sensitivity and specificity. STUDY DESIGN: Paired samples of first void urine and two urethral swabs were tested from 230 men, 73% of whom had symptoms of urethritis. Both specimen types were tested with IMX Select, the other swab was cultured, and a part of the first void urine was tested by Chlamydiazyme enzyme immunoassay. Performance calculations were made against urethral culture and an expanded gold standard that included direct fluorescent staining of discordant specimens by Microtrak. RESULTS: Compared with urethral swab culture, the IMX Select test performed on urethral swabs and first void urine had sensitivities of 93.8% and 81.3%, and specificities of 95.2% and 95.7%, respectively. Calculations of sensitivity and specificity based on the expanded gold standard were: IMX Select on urethral swabs, 88.5% and 99.4%; IMX Select on first void urine, 80.8% and 100%; Chlamydiazyme after blocking confirmation on first void urine, 73.1% and 100%; culture on urethral swabs, 61.5% and 100%. CONCLUSION: This IMX Select Chlamydia enzyme immunoassay, which generates laboratory results within 2 hours, performed better than culture and an established enzyme immunoassay on male urethral swabs. The experimental first void urine protocol showed promise for noninvasive male testing.
BACKGROUND AND OBJECTIVES: More information is needed on the natural history of Chlamydia trachomatis urethral infections in men. Newer assays for detecting antigens in male first void urine and urethral swabs identify patients for control programs. A new microparticle enzyme immunoassay from Abbott Laboratories called IMX Select Chlamydia was evaluated and compared with culture and an expanded gold standard for sensitivity and specificity. STUDY DESIGN: Paired samples of first void urine and two urethral swabs were tested from 230 men, 73% of whom had symptoms of urethritis. Both specimen types were tested with IMX Select, the other swab was cultured, and a part of the first void urine was tested by Chlamydiazyme enzyme immunoassay. Performance calculations were made against urethral culture and an expanded gold standard that included direct fluorescent staining of discordant specimens by Microtrak. RESULTS: Compared with urethral swab culture, the IMX Select test performed on urethral swabs and first void urine had sensitivities of 93.8% and 81.3%, and specificities of 95.2% and 95.7%, respectively. Calculations of sensitivity and specificity based on the expanded gold standard were: IMX Select on urethral swabs, 88.5% and 99.4%; IMX Select on first void urine, 80.8% and 100%; Chlamydiazyme after blocking confirmation on first void urine, 73.1% and 100%; culture on urethral swabs, 61.5% and 100%. CONCLUSION: This IMX Select Chlamydia enzyme immunoassay, which generates laboratory results within 2 hours, performed better than culture and an established enzyme immunoassay on male urethral swabs. The experimental first void urine protocol showed promise for noninvasive male testing.