1. Novel assay, NG-LFA, showed strong sensitivity and specificity compared to NG-PCR in both urine and vaginal specimens.

2. NG-MAST showed 93 different sequence types out of 156 LFA-positive specimens.

Evidence Rating Level: 2 (Good)

Study Rundown: To address the need for a rapid and cost-effective point-of-care test, a Neisseria gonorrhoeae novel lateral flow assay (NG-LFA) was developed to meet World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) criteria. This randomized controlled trial aimed to evaluate the NG-LFA’s performance in symptomatic male and female patients. The primary outcome of this study was the clinical sensitivity and specificity of the NG-LFA compared to Xpert CT/NG PCR assay, while key secondary outcomes were the multi-antigen sequence typing (NG-MAST) results. According to study results, the NG-LFA demonstrated excellent sensitivity and specificity in both male and female patients presenting with symptoms of urethral or vaginal discharge. However, the study’s generalizability may be limited by its cross-sectional design and focus on patients with primarily urethral or vaginal discharge.

Click to read the study in The Lancet

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In-depth [cross-sectional study]: Between Mar 7, 2022, and Sept 19, 2022, over 450 patients were screened for eligibility from 5 primary healthcare facilities in South Africa. Included were patients ≥ 18 years with symptoms of urethral or vaginal discharge. Altogether, 400 patients (200 males and 200 females) were included in the final analysis with the medial male age being 24 years (interquartile range [IQR] 21-31 years) and the median female age being 25 years (IQR 21-32 years). The primary outcome of NG-LFA sensitivity was 96.1% (123 LFA-positive of 128 PCR-positive) in urine specimens and 91.7% (33 LFA-positive of 36 PCR-positive) in vaginal swab specimens. Moreover, the specificity of NG-LFA was 97.2% (70 LFA-negative of 72 PCR-negative) in urine specimens and 96.3% (158 LFA-negative of 164 PCR-negative) in vaginal swab specimens. Findings from this study suggest that the NG-LFA demonstrates excellent sensitivity and specificity, meeting the criteria for a useful point-of-care test for Neisseria gonorrhoeae.

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