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. 2022 Feb 24;48(2-3):82–88. doi: 10.14745/ccdr.v48i23a05

Table 2. Performance of Reveal Rapid TP Antibody point-of-care-test and DPP Syphilis Screen and Confirm point of care test to detect active or infectious syphilis based on laboratory evaluation of 100 serum samples defined by traditional syphilis serological assaysa.

Performance characteristics of syphilis point-of-care test Reveal Rapid T. pallidum Antibodyb point-of-care testc DPP Syphilis Screen and Confirmd point-of-care testc
Overall sensitivitye 95.0% (90.0%) 87.5% (67.5%)
Sensitivityf 100% (100%) 100% (95.0%)
Sensitivityg 92.3% (84.6%) 76.9% (53.8%)
Sensitivityh 85.7% (71.4%) 71.4% (14.3%)
Specificity 83.3% (93.3%) 98.3% (100%)
False positive rate 16.7% (6.7%) 1.7% (0%)
False negative rate 5.0% (10.0%) 12.5% (32.5%)

a Traditional syphilis serological assays included chemiluminescent microparticle immunoassay (CMIA) followed by rapid plasma regain (RPR) and/or Venereal Disease Research Laboratory (VDRL) on those CMIA-positive

b MedMira Laboratories, Inc., Halifax, Nova Scotia

c Weakly reactive and very weakly reactive reactions were regarded as reactive (results were read conservatively with very weakly reactive reactions regarded as non-reactive). We chose to score the test results in more detail since reading intensity of colour change is subjective and difficulties in reading some syphilis point-of-care tests (POCTs) have been described by others

d ChemBio Diagnostic Systems, Inc., Medford, New York

e Overall sensitivity was based on 40 samples tested CMIA positive and RPR reactive or weakly reactive. The 40 active syphilis samples were subdivided into three categories: with strongly reactive VDRL titres (greater than 1:4); weakly reactive VDRL titres (1:2 to 1:4), and VDRL reactive only with undiluted serum or qualitative RPR weakly reactive

f Based on 20 samples tested CMIA positive, RPR reactive and VDRL titres greater than 1:4

g Based on 13 samples tested CMIA positive, RPR reactive and VDRL titres 1:2 to 1:4

h Based on n=7 samples tested CMIA positive, either RPR weakly reactive and/or VDRL reactive at undiluted