Urine Assay Encourages Men to Undergo Painless Chlamydia Test

The Chlamydia Rapid Test can be used with minimal training. It was designed to be used in conjunction with FirstBurst, a device for collecting the first voided urine from men, which collects six times the amount of Chlamydia bacteria compared to a standard urine sample.

Dr. Helen Lee, associate professor and reader in medical biotechnology at the University of Cambridge (Cambridge, UK), and colleagues developed the Chlamydia test. To commercialize the technologies developed at Cambridge, Dr. Lee founded the company, Diagnostics for the Real World Ltd. (DRW; Sunnyvale, CA, USA).

The team developed the Chlamydia Rapid Test on the signal-amplified system (SAS) for protein targets. It is based on multiplying a visual signal via an increase in the valence and size of the colored immune complex, by chemically coupling multiple copies of a hapten to the primary detection antibodies. The resulting lattice formed between the analyte, multiple hapten-labeled antibodies, and the antihapten color conjugate yields a strong visual signal.

Once diagnosed, chlamydia can be treated easily with a one-off antibiotic pill. However, until now, male rapid tests for chlamydia have been relatively inaccurate and involved urethral swabs, which can cause discomfort.

"Horror stories about painful swabs have put men off getting tested for chlamydia, and other noninvasive tests are expensive, technically complex, and take days to obtain the result," explained Dr Helen Lee. "This has led to many cases of infection in men going undiagnosed and being transmitted to their female partners, with potentially more serious complications."

In the majority of cases, the infection is asymptomatic in both men and women. If symptoms show in men, they may include discharge or pain when passing urine. It has been suggested that, if untreated, even when there are no observable symptoms, chlamydia may be a cause of reduced fertility. In women, the bacteria can lead to serious complications, such as pelvic inflammatory disease, chronic pelvic pain, and ectopic pregnancy.

In 2008, young people accounted for two-thirds of all new episodes of uncomplicated Chlamydia infection diagnosed in genitourinary medicine clinics. In England, as many 68 young men in every 1000 carry the infection, the figure is nearly 84 out of 1000 for young women. Since the mid-1990s, the number of diagnosed infections has risen by an average of 7500 per year to over 123,000.

A study describing the successful evaluation of the new Chlamydia test was published in the July 28, 2009 edition of the BMJ. The authors concluded, "The test could also provide a simple and reliable alternative to nucleic acid amplification assays for testing of male urine in chlamydial screening programs in high prevalence settings."

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