Reference Purpose Study design Sample size & characteristics Key results Major conclusions Validity
Herbst de Cortina et al. To determine sensitivity and specificity of dual HIV/Syphilis INSTI Multiplex downward flow immunoassay POC test Cohort study 200 convenience high risk serum samples, 14 of which were already diagnosed with primary Syphilis by PCR.
Peruvian men who have sex with men and transgender women. HIV: sens. 100% and speci. 95%
Syphilis: sens. 87.4% and speci. 97.0%. Excellent performance in comparison to routine methods. Further evaluations in other settings are needed to determine its performance in clinical settings. External: Subjects not representative of entire population.
Tests performed by trained laboratory personnel. …show more content…
98% to 99% speci. 94% to 100%
Syphilis: Sens. 93% to 95% speci. 97% to 100%
Kappa value among RTD’s: 0.95 These three RTD’s are an excellent choice for rapid POC diagnosis in areas where patients do not readily seek medical attention. Internal: enhanced by blinding laboratory technician to reference results.
External: Not representative of the entire population.
Leon et al. To determine sensitivity and specificity of Chembio DPP & demonstrate its relevance as a POC in a clinical setting Cohort study 450 convenience high risk serum samples: 100 positive for HIV, 99 positive for syphilis, 51 positive for coinfection.
Men who have sex with men and transgender women. HIV (both visual and electronic interpretation): sens. …show more content…
98.7%
Syphilis (visual interpretation): sens. 94.7% speci. 100%
Syphilis (electronic interpretation): sens. 94.7% speci. 99.7% The POC test performed similarly to reference studies, enhancing the potential use in clinical settings. Further studies using fingerprick samples are needed. Internal: enhanced by using an electronic reader and by repeating false results.
External: Not representative of population.
Tests performed by trained laboratory personnel.
Kalou et al. To evaluate the sensitivity and specificity of Chembio DPP and determine its reliability for international AIDS Relief plans. Prospective Cohort study 990 convenience high risk serum samples: 79 positive for HIV, 299 positive for syphilis, 348 positive for coinfection.
Subjects were deidentified. HIV: sens. 99.8% and speci. 98.4%
Syphilis: sens. 98.8% and speci. 99.4%. The performance of Chembio DPP is acceptable for inclusion in AIDS Relief plans in countries of high risk populations.
Further studies need to be conducted to determine its cost-effectiveness and how easily the test can be carried out by healthcare workers. Internal: Large sample
External: Not representative of population.
Test performed by laboratory trained personnel.
Bristow et
Herbst de Cortina et al. To determine sensitivity and specificity of dual HIV/Syphilis INSTI Multiplex downward flow immunoassay POC test Cohort study 200 convenience high risk serum samples, 14 of which were already diagnosed with primary Syphilis by PCR.
Peruvian men who have sex with men and transgender women. HIV: sens. 100% and speci. 95%
Syphilis: sens. 87.4% and speci. 97.0%. Excellent performance in comparison to routine methods. Further evaluations in other settings are needed to determine its performance in clinical settings. External: Subjects not representative of entire population.
Tests performed by trained laboratory personnel. …show more content…
98% to 99% speci. 94% to 100%
Syphilis: Sens. 93% to 95% speci. 97% to 100%
Kappa value among RTD’s: 0.95 These three RTD’s are an excellent choice for rapid POC diagnosis in areas where patients do not readily seek medical attention. Internal: enhanced by blinding laboratory technician to reference results.
External: Not representative of the entire population.
Leon et al. To determine sensitivity and specificity of Chembio DPP & demonstrate its relevance as a POC in a clinical setting Cohort study 450 convenience high risk serum samples: 100 positive for HIV, 99 positive for syphilis, 51 positive for coinfection.
Men who have sex with men and transgender women. HIV (both visual and electronic interpretation): sens. …show more content…
98.7%
Syphilis (visual interpretation): sens. 94.7% speci. 100%
Syphilis (electronic interpretation): sens. 94.7% speci. 99.7% The POC test performed similarly to reference studies, enhancing the potential use in clinical settings. Further studies using fingerprick samples are needed. Internal: enhanced by using an electronic reader and by repeating false results.
External: Not representative of population.
Tests performed by trained laboratory personnel.
Kalou et al. To evaluate the sensitivity and specificity of Chembio DPP and determine its reliability for international AIDS Relief plans. Prospective Cohort study 990 convenience high risk serum samples: 79 positive for HIV, 299 positive for syphilis, 348 positive for coinfection.
Subjects were deidentified. HIV: sens. 99.8% and speci. 98.4%
Syphilis: sens. 98.8% and speci. 99.4%. The performance of Chembio DPP is acceptable for inclusion in AIDS Relief plans in countries of high risk populations.
Further studies need to be conducted to determine its cost-effectiveness and how easily the test can be carried out by healthcare workers. Internal: Large sample
External: Not representative of population.
Test performed by laboratory trained personnel.
Bristow et