Evaluating the utility of the AF Genital System test for pathogen diagnosis in acute male urethritis

Abstract

This study evaluated the effectiveness of the A.F. Genital System (Liofilchem®, Italy) in detecting pathogens compared with multiplex real- time polymerase chain reaction (PCR) in men with acute urethritis. Men diagnosed as having acute urethritis between 1 April 2021 and 31 December 2021 were included. Urethral swab samples were ob-tained for A.F. Genital System and PCR testing in a randomly determined order. The efficacy of the A.F. Genital System was analysed by comparing the results of the two tests. The study included 83 patients (mean age 34.1 ± 11.3 years). A urethritis patho-gen was detected in 69 patients (83.1%) by PCR and only 15 patients (18.1%) with the A.F. Genital System. The sensitivity of the A.F. Genital System in detecting acute urethritis pathogens was 21.7% (95% confidence interval [CI]: 13.6– 32.8), and the specificity was 100% (95% CI: 78.5– 100). Its sensitivity was 20% (95% CI: 7.1– 45.2) in the diagnosis of gonococcal urethritis and 19.1% (95% CI: 11.2– 30.4) in the diagnosis of non- gonococcal urethritis. PCR detected two or more urethritis pathogens in 9 patients (13.0%), while no polymicrobial infection was detected with the A.F. Genital System. Based on the results of multiplex real- time PCR, the A.F. Genital System had very low sensitivity in the detection of pathogens in acute male urethritis. It should be kept in mind that using this test in patients with acute urethritis may result in a high missed diagnosis rate for urethritis pathogens.