Completed Pregnancy, Children & Inherited Conditions Digestion, Kidneys & Other Organs

Point of care nucleic acid-based duplex test for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoae (NG

Funder InnovateUK (part of UKRI)
Recipient organisation Diagnostics for the Real World (europe) Limited
Funding £1.4M
Period Sept 2010 — Jun 2014

In plain English

AI plain-English summary

A single self-collected urine sample or vaginal swab could soon diagnose both chlamydia and gonorrhoea in under an hour, without needing a laboratory. Current testing for these two sexually transmitted infections typically requires sending samples to a central lab, which means patients wait days for results and often do not return for treatment. This delay fuels onward transmission and makes contact tracing nearly impossible. The project aims to close that gap by developing a point-of-care test that gives clinicians a result while the patient is still in the clinic. The test, called SAMBA, uses a simple nucleic acid chemistry platform. Reagents come in unit-dose cartridges that remain stable without cold storage, and results appear on a lateral flow device readable by eye. The consortium has already developed a prototype and will now scale up production, validate the test, and run clinical trials for regulatory approval. If successful, the test could shift chlamydia and gonorrhoea management from a delayed, lab-dependent process to immediate diagnosis and treatment in a single clinic visit. This would improve infection control, reduce complications from untreated infections, and simplify contact tracing—particularly in settings with limited laboratory infrastructure.

View original technical description
The project objective is to develop a nucleic acid-based duplex test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) for point-of-care use. The project will be carried out by a consortium, composed of Diagnostics for the Real World (Europe) Ltd. and the Diagnostics Development Unit, University of Cambridge. The expertise brought by the consortium parties covers all activities required to conduct the project: product development; scale up; validation and clinical trials in health care settings for regulatory submission. The CT/NG duplex test is based on a simple nucleic acid chemistry platform called SAMBA (“Simplified AMplification Based Assay). Simple to collect and non-invasive samples will be used, such as self-collected vaginal swabs or urine collected by FirstBurst®, a unique and patented first-void urine collection device, which collects the first 3 ml of urine containing 84% of bacteria from a urine stream. The highly stable reagents are provided in unit-dose cartridges and the results can be visually read using a patented lateral flow device. The test can be easily carried out by minimally trained personnel at point of care settings and can provide results to clinicians while the patients are still at the clinic, thus allowing immediate treatment and efficient contact tracing.

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Related Research

Grants with similar aims, by meaning.

A rapid cost-effective and highly sensitive point of care platform for detection of Chlamydia and Gonorrhoea
Development of an Instrument-Free Molecular Diagnostic Test for Chlamydia and Gonorrhoea
Development of an ultra-rapid, point-of care diagnostic system for Chlamydia and gonorrhoea
Fast Point-of-Care Testing for Sexually Transmitted Diseases: Expanding the scope of testing
CLIENT: Clinic-based Infection Examination through Nucleic acid Technology

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