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Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy

(2017) SEXUALLY TRANSMITTED INFECTIONS. 93(suppl. 4). p.S51-S58
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Abstract
Objectives: The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. Methods: The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. Results: A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%-100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). Conclusion: The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM.
Keywords
TREPONEMAL ANTIBODIES, HIV

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Chicago
Zorzi, Antonella, Maddalena Cordioli, Lorenzo Gios, Paola Del Bravo, Igor Toskin, Rosanna W Peeling, Karel Blondeel, et al. 2017. “Field Evaluation of Two Point-of-care Tests for Syphilis Among Men Who Have Sex with Men, Verona, Italy.” Sexually Transmitted Infections 93 (suppl. 4): S51–S58.
APA
Zorzi, A., Cordioli, M., Gios, L., Del Bravo, P., Toskin, I., Peeling, R. W., Blondeel, K., et al. (2017). Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy. SEXUALLY TRANSMITTED INFECTIONS, 93(suppl. 4), S51–S58.
Vancouver
1.
Zorzi A, Cordioli M, Gios L, Del Bravo P, Toskin I, Peeling RW, et al. Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy. SEXUALLY TRANSMITTED INFECTIONS. 2017;93(suppl. 4):S51–S58.
MLA
Zorzi, Antonella et al. “Field Evaluation of Two Point-of-care Tests for Syphilis Among Men Who Have Sex with Men, Verona, Italy.” SEXUALLY TRANSMITTED INFECTIONS 93.suppl. 4 (2017): S51–S58. Print.
@article{8543134,
  abstract     = {Objectives: The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. 
Methods: The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen \& Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. 
Results: A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1\%) were TPPA-positive alone and 16 (5.5\%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99\% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4\% and 54.3\%, readers 1 and 2, respectively) compared with that on serum (80.0\% and 82.9\%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7\% and 64.0\% on serum vs 65.4\% and 69.2\% on fingerprick for the treponemal component; 63.6\% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100\% and 93.9\% for the treponemal component of both syphilis POCTs, but was lower (76.3\%-100\%)\%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90\% for both tests on both samples. The agreement between readers was very high ({\textrangle}99\%). 
Conclusion: The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM.},
  author       = {Zorzi, Antonella and Cordioli, Maddalena and Gios, Lorenzo and Del Bravo, Paola and Toskin, Igor and Peeling, Rosanna W and Blondeel, Karel and Cornaglia, Giuseppe and Kiarie, James and Ballard, Ronald and Mirandola, Massimo},
  issn         = {1368-4973},
  journal      = {SEXUALLY TRANSMITTED INFECTIONS},
  language     = {eng},
  number       = {suppl. 4},
  pages        = {S51--S58},
  title        = {Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy},
  url          = {http://dx.doi.org/10.1136/sextrans-2016-053065},
  volume       = {93},
  year         = {2017},
}

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