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Evaluation of an enzymatic Chlamydia trachomatis point-of-care rapid assay in Rwanda: the BioChekSwab Rapid Test
  1. Irith De Baetselier1,
  2. Lambert Mwambarangwe2,
  3. Vicky Cuylaerts1,
  4. Viateur Musengamana2,
  5. Stephen Agaba2,
  6. Evelyne Kestelyn2,3,
  7. Janneke van de Wijgert2,3,
  8. Tania Crucitti1
  1. 1Department of Clinical Sciences, HIV/STI Reference Laboratory, Institute of Tropical Medicine, Antwerp, Belgium
  2. 2Rinda Ubuzima, Kigali, Rwanda
  3. 3Institute of Infection and Global Health, University of Liverpool, Liverpool, UK
  1. Correspondence to Ms. Irith De Baetselier MSc. Department of Clinical Sciences, HIV/STI Reference Laboratory, Institute of Tropical Medicine, Nationalestraat 155, Antwerp 2000, Belgium; idebaetselier{at}itg.be

Abstract

Objectives We evaluated the performance of an enzymatic point-of-care rapid test for Chlamydia trachomatis (CT) (the BioChekSwab CT Rapid Test, EnZtek Diagnostics, Rio Vista, California, USA), which detects CT's Peptidase 123CBV enzyme and provides a result 15 min after specimen collection.

Methods Two endocervical swabs, including one BioChekSwab, per person were obtained from 137 women who participated in a reproductive health study in Rwanda. The BioChekSwab was processed according to the manufacturer's instructions. A substrate was squirted over the swab by the study physician immediately after collection, and another reagent was released over the swab tip at arrival in the laboratory. The test was considered positive if a blue colour developed within 2 min. The other regular flocked endocervical swab was processed at the Institute of Tropical Medicine (ITM), Belgium, using a testing algorithm: Abbott RealTime CT/Neisseria gonorrhoeae (NG) assay with the confirmation of positive results by an in-house real-time PCR assay.

Results Of the 137 women, nine were CT positive by the testing algorithm. All nine positive results were missed by the BioChekSwab assay and four false-positive results were obtained. The sensitivity was therefore 0% (95% CI 0% to 33.6%) and the specificity was 96.9% (95% CI 92.2% to 99.1%).

Conclusions The BioChekSwab Rapid Test, although ISO13485 certified and Conformitée Européenne (CE) labelled, lacked any sensitivity in our setting.

  • CHLAMYDIA TRACHOMATIS
  • DIAGNOSIS
  • DEVELOPING WORLD
  • LABORATORY METHODS
  • TESTING

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