As part of the World Health Organization (WHO) pre-qualification of in vitro diagnostics assessment, four dual HIV/Syphilis RDTs were evaluated between 2014 and 2016 by WHO at the Institute of Tropical Medicine (Antwerp, Belgium). SD Bioline HIV/Syphilis Duo (Standard Diagnostics, Republic of Korea, product number 06FK30; version instructions for use (IFU) 2013/05), DPP HIV-Syphilis Assay (Chembio Diagnostic Systems, United States, product number 659525; version IFU 10–6307-0Rev1) and Multiplo Rapid TP/HIV Antibody Test (Medmira, Canada, product number 815311005145; version IFU MPSIPYZIS0002EN Rev3/1) were evaluated simultaneously. The evaluation of Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test (bioLytical Laboratories, Canada, product number 90–1032; version IFU 50-1143E) was performed at a later time point. The SD Bioline and the DPP assay are lateral flow (immunochromatographic) RDTs while Multiplo and INSTI are RDTs based on the flow through (immunofiltration) principle. All assays were performed by one operator (blinded to the reference results) according to the manufacturer’s instructions for use (IFU). The test characteristics of the assays are described in Table 1 .
Test characteristics
SD Bioline HIV/Syphilis Duo | DPP HIV-Syphilis Assay | Multiplo Rapid TP/HIV Antibody Test | Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test | |
---|---|---|---|---|
Type of assay | Lateral flow immunochromatographic assay | Lateral flow immunochromatographic assay (dual path platform) | Vertical flow immunofiltration immunoassay (flow through) | Vertical flow immunofiltration immunoassay (flow through) |
Specimen | Serum, plasma, whole blood | Serum, plasma, whole blood | Serum, plasma, whole blood | Serum, plasma, whole blood |
Volume required | 10 μl of serum/plasma | 10 μl of serum/plasma | 1 drop of whole blood/serum/plasma (35-40 μl) | 50 μl of whole blood/serum/plasma |
20 μl of whole blood | 1 sample loop or 10 μl of whole blood | |||
Time to results | 15–20 min | 15–25 min | Once all fluid is absorbed | Immediately after adding the Clarifying Solution |
(+/− 3 min) | ||||
(+/− 1–2 min) | ||||
Equipment | Timer | Timer | None | None |
HIV component | HIV-1/2 recombinant antigens (gp41, gp36 and HIV-1 group O) | HIV-1/2 recombinant antigens (not specified) | HIV-1/2 synthetic peptides (gp36, gp41, gp120 and HIV-1 group O) | HIV-1/2 recombinant antigens (gp41, gp36) |
TP component | Recombinant antigen (17 kDa) | IgG/IgM recombinant antigen (not specified) | IgG/IgM recombinant antigens (15 kDa, 17 kDa, 47 kDa) | Recombinant fusion proteins derived from p17 and p47 domains |
Steps to perform | Add the specimen. | Add the specimen to the Sample Tainer (with buffer), mix. | Add 3 drops of buffer to the device. | Add the specimen to the Sample diluent vial, mix. |
Add 3 drops of diluent. | Add the specimen. | |||
Add 2 drops to the test device at Well 1. | Place the InstantGoldCap. | Add the content of this vial to the device. | ||
Add 4 drops of buffer to the test device at Well 2. | Add 12 drops of buffer. | Add the Colour Developer. | ||
Remove the InstantGoldCap. | Add the Clarifying Solution. | |||
Add 3 drops of buffer. | ||||
Result interpretation | Clear | Clear | Clear | There is no marker on the devices to indicate the position of the HIV, syphilis and control dot. |