New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study.
OBJECTIVE
To evaluate the performance of a new Chlamydia Rapid Test with vaginal swab specimens as a potential tool for chlamydia diagnosis and screening.


METHODS
Performance evaluation study. Settings A young people's sexual health centre (site 1) and two genitourinary medicine clinics (sites 2 and 3) in the United Kingdom.


METHODS
1349 women aged between 16 and 54 attending one of the three clinics.


METHODS
Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction and strand displacement amplification assays; correlation between the Chlamydia Rapid Test visual signal and organism load; acceptability to participants of self collected vaginal swabs as the specimen type for Chlamydia testing.


RESULTS
Polymerase chain reaction positivity rates for Chlamydia trachomatis infection were 8.4% (56/663) at site 1, 9.4% (36/385) at site 2, and 6.0% (18/301) at site 3. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test were 83.5% (91/109), 98.9% (1224/1238), 86.7% (91/105), and 98.6% (1224/1242). Compared with strand displacement amplification assay, sensitivity and specificity of the Chlamydia Rapid Test were 81.6% (40/49) and 98.3% (578/588). Organism load of self collected vaginal swabs ranged from 5.97x10(2) to 1.09x10(9) Chlamydia plasmids per swab, which correlated well with the Chlamydia Rapid Test's visual signal (r=0.6435, P<0.0001). Most (95.9%) surveyed participants felt comfortable about collecting their own swabs.


CONCLUSIONS
The performance of the Chlamydia Rapid Test with self collected vaginal swabs indicates that it would be an effective same day diagnostic and screening tool for Chlamydia infection in women. The availability of Chlamydia Rapid Test results within 30 minutes allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. It could also provide a simple and reliable alternative to nucleic acid amplification tests in chlamydia screening programmes.
Mahilum-Tapay
Lourdes
L
Diagnostics for the Real World (Europe) Ltd, Cambridge Science Park, Cambridge CB4 0WG.
Laitila
Vivian
V
Wawrzyniak
James J
JJ
Lee
Helen H
HH
Alexander
Sarah
S
Ison
Catherine
C
Swain
Alison
A
Barber
Penelope
P
Ushiro-Lumb
Ines
I
Goh
Beng T
BT
D000293:Adolescent; D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000517:prevention & control; D004269:DNA, Bacterial / Q000032:analysis; D005260:Female; D006801:Humans; D008828:Microbiological Techniques / Q000592:standards; D008875:Middle Aged; D017060:Patient Satisfaction; D019095:Point-of-Care Systems / Q000592:standards*; D016133:Polymerase Chain Reaction; D013048:Specimen Handling; D014626:Vaginal Smears / Q000592:standards
D004269:DNA, Bacterial