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See Chlamydia Rapid Test Product Insert for specific details on preparation, procedures, quality control, and interpretation of test results.
The One-Step Chlamydia Test is intended for in vitro diagnostic use in the rapid, qualitative detection of Chlamydia trachomatis directly from female endocervical swab and male urethral swab, in addition to ocular specimens from symptomatic patients.
Our New BMJ website does not support IE6 please upgrade your browser to the latest version or use alternative browsers suggested below. Acceptability of FirstBurst device and waiting time for resultAfter specimens had been collected from the men in site 2, each participant was offered a written questionnaire. The Chlamydia Rapid Test is a meaningful test for point-of-care diagnosis of a chlamydia infection. If using swab, specimen or from a patient is treated with extraction reagent A and B to extract the antigen. DIYTrade accepts no responsibility whatsoever in respect of such content.To report fraudulent or illegal content, please click here. This Chlamydia Rapid Test is a quick, simple, and non-invasive test for use on female patients only. If Chlamydia trachomatis antigen is present, the labeled antibody dye conjugate bind to it, forming an antibody antigen complex.
For more information about Rapid tests, CLIA tests, IFA kits, or ELISA test kits, please contact our Customer Service Representatives at 818-591-3030 . Other methods include direct fluorescence assays (DFA), enzyme immunoassays (EIA), and nucleic acid probing. 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.
Participants were not asked to give a urethral swab so for those men who had not experienced urethral swabbing their expressed preference might not be valid. 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 ranges in brackets are the extreme scenarios, using both the lower and upper 95% confidence interval estimates for positive and negative concordance in our imputation.Table 1 ?Unresolved and resolved* performance with Chlamydia Rapid Test versus polymerase chain reaction.
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.IntroductionChlamydia trachomatis infection is the most common sexually transmitted bacterial infection in the United States and United Kingdom. In the US in 2006, the number of cases of genital C trachomatis infection reported to the Centers for Disease Control and Prevention exceeded one million for the first time.1 This number has increased annually for more than two decades, probably because of a combination of a true increase in prevalence, more widespread screening, the availability of more sensitive tests, and more complete national reporting. This new test provides same day results, allowing for immediate treatment of infected patients. In the UK, the number of diagnoses of uncomplicated chlamydial infection in genitourinary medicine clinics has also climbed steadily since the mid-1990s. Between 2005 and 2006, it increased by 4% (from 109?418 to 113?585), with the number remaining stable in women but increasing by 8% in men.2Chlamydial infection is commonly asymptomatic and remains underdiagnosed. C trachomatis infects the urethral mucosa in men, and this tissue is usually sampled either with urethral swabs or first void urine.
The participants in our study preferred urine samples because of the discomfort associated with swab collection. Furthermore, the availability of a high performance, rapid, and simple to use test would allow the implementation of a test and treat regimen, whereby patients are treated on site during the initial visit. We recently showed that the chlamydial load in first void urine does not differ significantly from that of urethral swabs.15 To facilitate the reliable collection of the first void urine samples, we used a new urine collection device (FirstBurst), which is provided with the Chlamydia Rapid Test kit. The use of rapid tests can result in the treatment of more infected individuals than the use of nucleic acid amplification tests if the return rate is less than 65%.7 Nucleic acid amplification tests are commonly used for chlamydial diagnosis and are more sensitive than enzyme immunoassay based tests.
We analysed the DNA extracted from these urine specimens with quantitative polymerase chain reaction assay with a primer set that amplifies a highly conserved sequence of the 7.5-kb cryptic plasmid of C trachomatis.


Nucleic acid amplification tests, however, take hours or days (if re-testing is required) to complete and are costly. While results of laboratory based tests usually take many days to reach the clinics, currently available rapid tests for the detection of chlamydia in male urine lack the required sensitivity, even when used in a test and treat setting.8We have evaluated the performance of a new Chlamydia Rapid Test, developed at the diagnostics development unit of the University of Cambridge. This finding is not unexpected because of the different prevalence rates at the respective study sites.
The assay is used in conjunction with a collection device for male urine (FirstBurst),9 10 specifically designed to collect the first voided urine that contains a higher organism load, and test results are available in less than an hour. This assay was developed to aid in the diagnosis of chlamydial infection and to provide a screening tool for the detection of such infection among young sexually active males.MethodsSitesThe evaluation sites comprised a young people’s sexual health centre (Brook in Birmingham, site 1) and a genitourinary medicine clinic (Ambrose King Centre in London, site 2). Given that men do not get tested for chlamydia as often as women do, as well as the inevitable delay in obtaining results with currently available testing methods, men with asymptomatic chlamydial infection continue to provide a transmission link for the disease that is missed by current testing programmes. Participants were recruited from March to November 2007.ParticipantsAll men attending the two sites were invited to join the study.
Prevention of the spread of disease will thus require a high performance rapid test for chlamydia that allows for a test and treat regimen, in addition to the existing nucleic acid amplification tests. They were eligible for enrolment if they were aged at least 16, had not taken antibiotics in the previous month, and were able to understand the written information forms for the study.
Emerging concerns regarding the role of chlamydia in male subfertility might encourage more asymptomatic men to come forward for screening.5 6The performance of the Chlamydia Rapid Test is clearly related to the organism load within the specimen.
Higher loads have been associated with increased chlamydia positivity in tested sexual partners, suggesting that those with higher loads are more infectious.17 This was confirmed in our study, where we observed a higher positivity rate (30% with polymerase chain reaction v 25% with the Chlamydia Rapid Test) in men who attended because of contact tracing. Participants gave written informed consent and were then interviewed confidentially about their symptoms and relevant sexual history. Men who tested positive with the Chlamydia Rapid Test are thus likely to be the most infectious, and rapid removal of these infected men from the reservoir of infection with a test and treat regimen might have an advantage over traditional screening approaches. Participants at site 2 also filled in a written questionnaire concerning sample collection methods and preferences after they had provided a sample.Specimen collectionEach participant provided two urine samples, the first one collected using a FirstBurst urine collection device9 that collects the first 4-5 ml of urine.
This hypothesis warrants further investigation in appropriately designed trials.Reliance on nucleic acid testing alone can be problematic, depending on the target used in the assay. Following the manufacturers’ instructions (Roche and Gen-Probe), the second urine specimen was collected with a collection cup routinely used in sexually transmitted disease clinics in the UK at least two hours after the FirstBurst specimen was collected. Specific diagnostic tests for chlamydia are rarely available in these regions and management is often based on self reported symptoms and clinical signs, thus missing asymptomatic men altogether. Given the high prevalence of chlamydial infection among sex workers in these settings,20 male customers are likely to transmit infection to their other sexual partners and should therefore be among the primary targets for chlamydia testing.Strengths and weaknesses of the studyThis study included two centres with relatively large population sizes at sites with low and high prevalence.
We used confirmatory testing on discordant samples to resolve true chlamydial positivity and additional random testing to minimise the bias from “selective” analysis of discordant samples. The resulting supernatant was discarded and the pellet was subjected to extraction by the sequential addition of 400 µl of reagent 1, 300 µl of reagent 2, and 100 µl of reagent 3, with mixing between additions. In addition, there was high reproducibility of testing between operators, strengthening the validity of the laboratory methods.
We then added 100 µl of the extracted sample to a tube containing lyophilised amplification and detection reagents.
The Chlamydia Rapid Test specimens were collected from men who had not had to hold their urine for two hours, thus providing applicability in a real world setting without the time restrictions imposed by traditional testing algorithms.The number of men positive for chlamydia at site 1 was low because of the low prevalence nature of this site. The resulting mixture was gently agitated until it became a clear pink solution, after which we added the test strip to the solution and allowed it to stand for 25 minutes before reading the result. The 95% confidence intervals for the sensitivity of the Chlamydia Rapid Test were larger at site 1 than at site 2.
The test strip contains a monoclonal antibody to chlamydial lipopolysaccharide12 at the test line and includes a separate procedural control line.


Also, in the determination of chlamydia load, the reference curve was based on purified plasmid preparations in buffer, therefore we could not control for inhibitory substances potentially present in some urine specimens.Future researchFuture studies should focus on determining whether the widespread use of the Chlamydia Rapid Test in screening young men for chlamydial infection in high prevalence settings can help prevent sequelae among their female sexual partners. The appearance of a result line on the test strip indicated the presence of chlamydia, which was further graded with a semi-quantitative in-house grading card.Testing with polymerase chain reaction and transcription mediated amplificationThe performance of the Chlamydia Rapid Test was assessed to meet the requirements for Conformite Europeenne licensure, which stipulate that the comparator test should be a “state of the art” assay and should be performed with specimens approved for the test. In addition, more studies are warranted to verify whether the Chlamydia Rapid Test would reassure young men that testing can be quick, simple, and non-invasive, and this might increase uptake. Polymerase chain reaction testing for chlamydia, which is licensed for urine specimens, was chosen as the ideal standard test for the study. The rapid test might also be used to confirm the chlamydia status in men with symptomatic non-gonococcal urethritis at the point of care, thus allowing more efficient contact tracing and focusing the health promotion resources on these individuals at the time of testing. Any potential improvement of the outcome over current approaches with nucleic acid amplified based screening should be evaluated in relation to alternative strategies.
Samples that yielded discordant results with the Chlamydia Rapid Test and the polymerase chain reaction assay were tested with the mono-specific Aptima CT kit, a transcription mediated amplification assay (Gen-Probe, San Diego, CA) according to manufacturer’s instructions at the Sexually Transmitted Bacteria Reference Laboratory (Health Protection Agency, Colindale).
Finally, to further reduce the testing time of the rapid test, it might be worth exploring the use of urethral swab, especially in genitourinary medicine clinics that routinely collect urethral smears. This advantage, however, should be balanced with the fear in men of urethral procedures, which abounds in genitourinary medicine clinics, not only among those who have attended previously.21ConclusionsThe new Chlamydia Rapid Test for urine samples from men showed high sensitivity and specificity that can produce results within an hour. It is therefore suitable as a primary diagnostic tool, especially in settings where patients need to be tested and treated in one visit.
It could also be used as a screening tool in areas with a high prevalence of infection or in settings where access to nucleic acid amplification tests is limited or where the return rate is low.
With 120 positive results, this would mean less than 7% margin of error for our estimates.Of the 66 excluded participants, 47 had incomplete specimen sets, seven withdrew, and the rest were excluded because of deviations from testing protocol.
E-CN wrote the first draft of the manuscript and led in the manufacture of the Chlamydia Rapid Test kits used in the study. Figure 1 shows the recruitment and testing algorithm for the study participants at both clinical sites?. Most participants at site 1 attended the sexual health centre for contraception and other reproductive health services and were asymptomatic. Risk behaviours, medical care, and chlamydial infection among young men in the United States.
Coverage and uptake of systematic postal screening for genital Chlamydia trachomatis and prevalence of infection in the United Kingdom general population: cross sectional study.
Demonstration of Chlamydia trachomatis IgG antibodies in the male partner of the infertile couple is correlated with a reduced likelihood of achieving pregnancy. Frequency of sperm cells with fragmented DNA in males infected with Chlamydia trachomatis and Mycoplasma sp, determined with the sperm chromatin dispersion (SCD) test. Impact of reference standard sensitivity on accuracy of rapid antigen detection assays and a leukocyte esterase dipstick for diagnosis of Chlamydia trachomatis infection in first-void urine specimens from men.
Optimal collection of first-void urine for detection of Chlamydia trachomatis infection in men.
European patent 2003771170, November 2007.?National Committee on Clinical Laboratory Standards. Field evaluation of a rapid point-of-care assay for targeting antibiotic treatment for trachoma control: a comparative study. Reliability of nucleic acid amplification methods for detection of Chlamydia trachomatis in urine: results of the first international collaborative quality control study among 96 laboratories.




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