title: Performance evaluation of a new rapid urine test for chlamydia in men: prospective cohort study.
abstract: 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.
  
  
  METHODS
  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.
  
  
  METHODS
  1211 men aged 16-73 attending either of the two sites.
  
  
  METHODS
  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 7.28x10(2) to 6.93x10(6) 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.
authors.affiliation: Diagnostics for the Real World (Europe), Cambridge Science Park, Cambridge CB4 0WG.
authors.forename: Elpidio-Cesar
authors.initials: EC
authors.lastname: Nadala
authors.forename: Beng T
authors.initials: BT
authors.lastname: Goh
authors.forename: Jose-Paolo
authors.initials: JP
authors.lastname: Magbanua
authors.forename: Penelope
authors.initials: P
authors.lastname: Barber
authors.forename: Alison
authors.initials: A
authors.lastname: Swain
authors.forename: Sarah
authors.initials: S
authors.lastname: Alexander
authors.forename: Vivian
authors.initials: V
authors.lastname: Laitila
authors.forename: Claude-Edouard
authors.initials: CE
authors.lastname: Michel
authors.forename: Lourdes
authors.initials: L
authors.lastname: Mahilum-Tapay
authors.forename: Ines
authors.initials: I
authors.lastname: Ushiro-Lumb
authors.forename: Catherine
authors.initials: C
authors.lastname: Ison
authors.forename: Helen H
authors.initials: HH
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D011934:Reagent Strips; D012680:Sensitivity and Specificity; D016482:Urinalysis / Q000523:psychology / Q000592:standards*; D055815:Young Adult
chemical_list: D011934:Reagent Strips