TY - JOUR
T1 - Performance evaluation of a new rapid urine test for chlamydia in men
T2 - Prospective cohort study
AU - Nadala, Elpidio Cesar
AU - Goh, Beng T.
AU - Magbanua, Jose Paolo
AU - Barber, Penelope
AU - Swain, Alison
AU - Alexander, Sarah
AU - Laitila, Vivian
AU - Michel, Claude Edouard
AU - Mahilum-Tapay, Lourdes
AU - Ushiro-Lumb, Ines
AU - Ison, Catherine
AU - Lee, Helen H.
PY - 2009/8/15
Y1 - 2009/8/15
N2 - Objective: To evaluate the performance of a rapid test for chlamydia with first void male urine samples as a potential tool for diagnosis and screening of chlamydial infection in men. Design: Evaluation of test performance in prospective cohort study. Settings: A young people's sexual health centre (site 1) and a genitourinary medicine clinic (site 2) in the United Kingdom. Participants: 1211 men aged 16-73 attending either of the two sites. Main outcome measures: Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction assay. Relation between the visual signal of the Chlamydia Rapid Test and organism load. Results: Detection rates for Chlamydia trachomatis infection with polymerase chain reaction were 4.4% (20/454) at site 1 and 11.9% (90/757) at site 2. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test was 82.6% (90/109), 98.5% (1085/1102), 84.1% (90/107), and 98.3% (1085/1104), respectively. The organism load in first void urine samples that were positive for chlamydia ranged from 7.28×10 2 to 6.93×106 plasmids/ml and correlated significantly with the visual signal of the Chlamydia Rapid Test (r=0.7897, P<0.001). Conclusions: The performance of the new Chlamydia Rapid Test with first void male urine samples indicates that it would be an effective diagnostic tool for chlamydial infection in men. The availability of test results within an hour allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. The test could also provide a simple and reliable alternative to nucleic acid amplification assays for testing of male urine in chlamydial screening programmes in high prevalence settings.
AB - Objective: To evaluate the performance of a rapid test for chlamydia with first void male urine samples as a potential tool for diagnosis and screening of chlamydial infection in men. Design: Evaluation of test performance in prospective cohort study. Settings: A young people's sexual health centre (site 1) and a genitourinary medicine clinic (site 2) in the United Kingdom. Participants: 1211 men aged 16-73 attending either of the two sites. Main outcome measures: Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction assay. Relation between the visual signal of the Chlamydia Rapid Test and organism load. Results: Detection rates for Chlamydia trachomatis infection with polymerase chain reaction were 4.4% (20/454) at site 1 and 11.9% (90/757) at site 2. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test was 82.6% (90/109), 98.5% (1085/1102), 84.1% (90/107), and 98.3% (1085/1104), respectively. The organism load in first void urine samples that were positive for chlamydia ranged from 7.28×10 2 to 6.93×106 plasmids/ml and correlated significantly with the visual signal of the Chlamydia Rapid Test (r=0.7897, P<0.001). Conclusions: The performance of the new Chlamydia Rapid Test with first void male urine samples indicates that it would be an effective diagnostic tool for chlamydial infection in men. The availability of test results within an hour allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. The test could also provide a simple and reliable alternative to nucleic acid amplification assays for testing of male urine in chlamydial screening programmes in high prevalence settings.
UR - http://www.scopus.com/inward/record.url?scp=69449105312&partnerID=8YFLogxK
U2 - 10.1136/bmj.b2655
DO - 10.1136/bmj.b2655
M3 - Article
C2 - 19638650
AN - SCOPUS:69449105312
SN - 0959-8146
VL - 339
SP - 389
JO - BMJ (Online)
JF - BMJ (Online)
IS - 7717
ER -