Table 1

Comparison of dual RDT and single-pathogen HIV and syphilis test characteristics and procedures*

Characteristics/proceduresHIV/syphilis rapid test
Chembio Dual Path Platform HIV-Syphilis Assay (Chembio DPP®, USA) 
(Investigational RDT)		HIV rapid test
Alere Determine™ HIV-1/2, Ireland
(‘First-line’ RDT)		Syphilis rapid test
Alere Determine™ Syphilis TP, Ireland
(‘First-line’ RDT)
Test deviceCartridgeSingle stripSingle strip
Sample typeWhole bloodWhole bloodWhole blood
Sample collection and volume10 µL Loop50 µL Capillary tube50 µL Capillary tube
Number of buffers/diluents2†
SampleTainer (black-top bottle)
Running buffer (green-top bottle)		1
Chase buffer		1
Chase buffer
Buffer/diluent volume2 drops (SampleTainer), well 1
4 drops (running buffer), well 2		1 drop chase buffer1 drop chase buffer
Run timeWell 1: 5 min
Well 2: 10 min		15 min15 min
Valid reading time frame10–25 min15–60 min15 min–24 hours
Storage conditions2°C–30°C (36°F–86°F)2°C–30°C (36°F–86°F)2°C–30°C (36°F–86°F)
Shelf life24 months14 months18 months
Package contentsProduct insert
20 test units
20 blood collection loops
20 sample collection bottles (1 mL)
1 buffer bottle (6 mL)		Product insert
20 or 100 test units
(buffer and capillary tubes not included)		Product insert
30 or 100 test units
(buffer and capillary tubes not included)

  • *The RDT for HIV and syphilis used in Malawi, at the time of this study, consist of single-pathogen RDTs (Alere Determine™ HIV-1/2 and Alere Determine™ Syphilis TP, Ireland) and HIV confirmatory testing is conducted using Uni-Gold™ Recombigen® HIV (Trinity Biotech, Ireland); confirmatory tests are not conducted for syphilis.

  • †The running buffer and sample diluent system requires application of two separate reagents at two separate locations, each collected blood is initially dispensed into a small SampleTainer bottle (black top) as a ‘resting spot’ for the sample itself allowing homogenous dispersion of the blood solution applied on the test cartridge (well 1).

  • RDT, rapid diagnostic test.