New rapid gonorrhoea test demonstrates high accuracy with many benefits
Written By : Aditi
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-08 20:15 GMT | Update On 2024-02-08 20:15 GMT
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According to a study published in The Lancet, researchers from the US, South Africa, and Swiss developed a low-cost, rapid point-of-care test for gonorrhea that met sensitivity and specificity requirements in symptomatic male and female patients in South Africa.
Developing an affordable and rapid point-of-care test for Neisseria gonorrhoeae control is crucial. According to the WHO and FIND, a non-molecular N gonorrhoeae rapid point-of-care test with a clinical sensitivity of over 80% and specificity of over 95% is necessary for syndromic management. The test should have a turnaround time of 30 minutes or less and cost less than US$3. A lateral flow assay (LFA) was developed to meet these requirements.
In this study, researchers evaluated the effectiveness of the novel N gonorrhoeae lateral flow assay (NG-LFA) at primary healthcare facilities in South Africa. They recruited patients with urethral ( 200 male patients of mean age 24 ) or vaginal discharge (200 female patients of mean age 25)syndrome from five facilities in the Buffalo City Metropolitan Municipality health district. They tested their first-void urine or nurse-collected vaginal swab samples using the NG-LFA and Xpert CT/NG PCR assay. They also performed N gonorrhoeae multi-antigen sequence typing (NG-MAST) on all LFA-positive specimens. Additionally, 23 male and 12 female patients with partner notification slips were enrolled, and among them, one male (4%) and five females (42%) were symptomatic.
Key findings from the study are:
- NG-LFA and Xpert results were available for all participants.
- NG-LFA sensitivity was 96·1% in urine specimens and 91·7% in vaginal swab specimens.
- The specificity was 97·2% in urine specimens and 96·3% in vaginal specimens.
- In 156 LFA-positive specimens, NG-MAST showed 93 different sequence types.
The NG-LFA accurately identified N gonorrhoea in symptomatic patients at primary healthcare centres in South Africa. Due to its ease of use and affordability, this method can revolutionize the syndromic management of gonorrhoea and decrease unnecessary antibiotic use in low- and middle-income countries.
GAMRIF and the National Institutes of Health funded the study.
Reference:
Peters et al. Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation. The Lancet. https://doi.org/10.1016/s0140-6736(23)02240-7
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