Laboratory Evaluation of the Chembio DPP Syphilis Screen & Confirm Point-of-Care Test on Serum and Simulated Blood Samples.

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.