Optimal Method of Collection of First-Void Urine for Diagnosis of Chlamydia trachomatis Infection in Men

Abstract

First-void urine (FVU) is the preferred specimen for the diagnosis of urogenital Chlamydia trachomatis infection in men. We have developed FirstBurst, a urine collection device that collects the first 4 to 5 ml of FVU and yields a specimen with a sixfold higher C. trachomatis organism load than the regular urine cup by quantitative PCR (32,533 versus 5,271 plasmids/ml; P < 0.0001). Consequently, the use of FirstBurst to collect a urine sample improved the sensitivity of a rapid test for Chlamydia over testing of samples collected with a urine cup (82 versus 47% sensitivity using PCR as a reference; P < 0.0015).Urogenital infection with Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection and continues to be a major public health problem worldwide (5, 17). Untreated C. trachomatis infections can lead to serious sequelae such as pelvic inflammatory disease in women and epididymitis in men (5). A large proportion of infected individuals either have mild symptoms or are asymptomatic (2). Thus, screening of high-risk populations has been recommended (4).The use of the invasive and painful urethral swab is a major barrier to screening of asymptomatic men and is a key factor in male nonattendance at genitourinary medicine clinics (7, 16). However, the development of highly sensitive nucleic acid amplification tests (NAATs) has allowed the use of first-void urine (FVU) for C. trachomatis diagnosis. FVU has become the specimen of choice for the diagnosis of urethral C. trachomatis infection in men by NAATs, since it is noninvasive and yet allows the detection of infected epithelial cells and associated C. trachomatis particles (3, 9). The volume of FVU has been defined arbitrarily as the first 20 to 30 ml of the initial flush of urine, which is thought to contain the highest concentration of diagnostically relevant components, such as C. trachomatis elementary bodies or antigens or inflammation-related enzymes (6). However, the optimal volume for an FVU specimen is unknown, and early attempts to study the organism load in FVU fractions have encountered difficulties due to the lack of a suitable sample collection device. At present, collection volumes for FVU ranging from 5 to 40 ml for men (8,15) and from 10 to 50 ml for women (13) are deemed to be acceptable samples.We have developed a novel FVU collection device called FirstBurst (10), which allows the convenient collection of the first 4 to 5 ml of FVU without dilution by the subsequent urine stream (Fig. 1A). We compared the C. trachomatis organism loads of FirstBurst-and urine cup-collected specimens and evaluated the sensitivity of a novel rapid test for Chlamydia using these two urine specimen types. In addition, we quantified the organism loads in four fractions of FVU from C. trachomatis-infected men by using a tandem of FirstBurst devices to further define the C. trachomatis load of the FVU specimen.Participants for the study comparing C. trachomatis loads between the FirstBurst device and the urine cup and for the study ...

Field evaluation of the CRT and ACON chlamydia point-of-care tests in a tropical, low-resource setting

“…Four publications on CRT performance authored between 2007 and 2009 reported CRT sensitivities for male ‘First Burst’ urine between 82% and 82.6%,17 19 and for CRT female vaginal swabs between 71% and 86.8%;20 21 a systematic review of these studies reported pooled estimates of CRT sensitivity and specificity for male first-void urine specimens to be 77% and 99%, and for female vaginal swabs to be 80% and 99% 22…”

“…The First Burst yields an approximately sixfold higher organism load per mL of urine than a routine cup-collected specimen 17. Where two samples were collected for CRT and ACON, collection order was alternated.…”

High prevalence and incidence of HIV, sexually transmissible infections and penile foreskin cutting among sexual health clinic attendees in Papua New Guinea

“…In men with urethral discharge, a urethral swab was collected for chlamydia, gonorrhoea and T. vaginalis. In men without urethral discharge, a first-void urine specimen (or a sample no less than 3 h after previous micturition) 22 was collected for the detection of these STIs. A 10-mL venepuncture blood specimen was collected at baseline and scheduled clinical follow-up visits for syphilis and herpes simplex virus Type 2 (HSV-2).…”

Analytical Pitfalls and Challenges in Clinical Metabolomics

“…The time point of urine collection during micturition may significantly affect the urinary composition, mainly due to bacterial contamination. A mid-stream urine sample is usually favored, except when studying urinary tract infections where first-void volume is preferred [36,37]. Finally, in large-scale human metabolomics studies, samples are frequently collected at different sites.…”