Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2024
Laboratory Evaluation of the Chembio DPP Syphilis Screen & Confirm Point-of-Care Test on Serum and Simulated Blood Samples.
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Ei Richmond Meika, Hoang William, Shuel Michelle, Titus Joshua, Van Caeseele Paul, Stein Derek R, Tsang Raymond Sw
Аннотация
INTRODUCTION: Syphilis infections are increasing in Canada, and traditional serological diagnostics pose barriers for vulnerable and marginalized populations at greatest risk. Point-of-care tests (POCTs) offer solutions, yet none were available in Canada until recently. The Chembio Dual Path Platform (DPP) Syphilis Screen & Confirm (SSC) is one of the first POCTs that helps distinguish active infection from non-infectious syphilis. This study evaluates the reliability of the Chembio DPP SSC to diagnose syphilis infection.
METHODS: One hundred clinical samples with known syphilis serology (chemiluminescent microparticle immunoassay [CMIA] and rapid plasma regain [RPR]) results were used to evaluate the Chembio DPP SSC. CMIA-ve (n = 20), CMIA+ve RPR-ve (n = 40), and CMIA+ve RPR+ve (n = 40) samples represented negative, past, and presumed active infection, respectively. Samples were used in two formats: serum and simulated blood. Two laboratory technicians read the test visually, and with the manufacturer's DPP Micro Reader, in blinded fashion.
RESULTS: Overall sensitivity of the Chembio DPP SSC to distinguish presumed active infection from non-infectious syphilis (past infection and no infection) with visual reads were 52.50% (serum) and 55.00% (simulated blood). Sensitivity increased using the DPP Micro Reader to 90.00% (serum) and 97.50% (simulated blood). Specificity with visual reads were 98.33% (serum) and 95.00% (simulated blood) compared to Micro Reader results of 88.30% (serum) and 80.00% (simulated blood). For the non-treponemal portion of the POCT with visual reads, the sensitivity increased with increasing RPR titers. Low RPR titers <1:4 only had a sensitivity of 42.86% (serum) and 14.29% (simulated blood).
DISCUSSION: The laboratory evaluation of the Chembio DPP SSC shows promise in detecting active syphilis, particularly in samples with RPR titers >1:4. However, the need for the Micro Reader for more accurate results is a limitation of the POCT, and financial constraints may pose barriers to some users. Further field evaluation is warranted.
METHODS: One hundred clinical samples with known syphilis serology (chemiluminescent microparticle immunoassay [CMIA] and rapid plasma regain [RPR]) results were used to evaluate the Chembio DPP SSC. CMIA-ve (n = 20), CMIA+ve RPR-ve (n = 40), and CMIA+ve RPR+ve (n = 40) samples represented negative, past, and presumed active infection, respectively. Samples were used in two formats: serum and simulated blood. Two laboratory technicians read the test visually, and with the manufacturer's DPP Micro Reader, in blinded fashion.
RESULTS: Overall sensitivity of the Chembio DPP SSC to distinguish presumed active infection from non-infectious syphilis (past infection and no infection) with visual reads were 52.50% (serum) and 55.00% (simulated blood). Sensitivity increased using the DPP Micro Reader to 90.00% (serum) and 97.50% (simulated blood). Specificity with visual reads were 98.33% (serum) and 95.00% (simulated blood) compared to Micro Reader results of 88.30% (serum) and 80.00% (simulated blood). For the non-treponemal portion of the POCT with visual reads, the sensitivity increased with increasing RPR titers. Low RPR titers <1:4 only had a sensitivity of 42.86% (serum) and 14.29% (simulated blood).
DISCUSSION: The laboratory evaluation of the Chembio DPP SSC shows promise in detecting active syphilis, particularly in samples with RPR titers >1:4. However, the need for the Micro Reader for more accurate results is a limitation of the POCT, and financial constraints may pose barriers to some users. Further field evaluation is warranted.