Background
Methods
Assays
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. |
Evaluation protocol
Panels
WHO specimen reference panel
Commercial sera panels
Performance and operational characteristics/statistics
Results
WHO specimen reference panel
RDT | HIV antibodies | Treponema pallidum antibodies | Final invalid rate (%) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | Inter-reader variability (%) | Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | Inter-reader variability (%) | ||||||
Initial | Final | Initial | Final | Initial | Final | Initial | Final | ||||
SD Bioline HIV/Syphilis Duo | 100 (98.2–100) | 100 (98.2–100) | 99.5 (97.2–100) | 99.5 (97.2–100) | 0 | 86.5 (81.0–90.9) | 87.0 (81.5–91.3) | 99.5 (97.2–100) | 99.5 (97.2–100) | 4.0 | 0 |
DPP HIV-Syphilis Assay | 100 (98.2–100) | 100 (98.2–100) | 96.0 (92.3–98.3) | 97.5 (94.3–99.2) | 1.0 | 85.0 (79.3–89.6) | 86.5 (81.0–90.9) | 100 (98.2–100) | 100 (98.2–100) | 4.5 | 0 |
Multiplo Rapid TP/HIV Antibody Test | 99.5 (97.2–100) | 99.5 (97.2–100) | 99.5 (97.2–100) | 99.5 (97.2–100) | 0.3 | 70.0 (63.1–76.3) | 73.5 (66.8–79.5) | 99.0 (96.4–99.9) | 99.5 (97.2–100) | 4.8 | 0.5 |
Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test | 99.5 (97.2–100) | 99.5 (97.2–100) | 88.0 (82.7–92.2) | 93.5 (89.1–96.5) | 4.5 | 78.5 (72.2–84.0) | 81.0 (74.9–86.2) | 99.0 (96.4–99.9) | 99.0 (96.4–99.9) | 1.8 | 0 |
Anti-HIV detection component
WHO N° | Origin | Result for HIV antibodies | Reference Results Treponema pallidum | Reference Results HIV | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
INSTI Multiplex HIV-1/HIV-2/Syphilis antibody test | DPP HIV/Syphilis Assay | SD Bioline HIV/Syphilis Duo | Multiplo rapid TP/HIV Antibody test | |||||||||||||||||||||||||
Vitros Syphilis TPA assay | TP particle agglutination (TTPA) | Reference result for TP | Vironostika HIV Ag/Ab | Genscreen HIV 1/2 v2 | Innotest HIV Ag mAb | InnoLIA HIV1/2 Score | Reference result for HIV | |||||||||||||||||||||
Initial | Final | Initial | Final | Initial | Final | Initial | Final | S/CO | Result | Result | OD/CO | Result | OD/CO | Result | OD/CO | Result | gp120 | gp41 | p31 | p24 | p17 | gp105 | gp36 | |||||
140,235 | Australia | FN | FN | OK | OK | OK | OK | FN | FN | 89.10 | R | 640 | R | Positive | 16.80 | R | 33,68 | R | 0.70 | NR | 1+ | 1+ | – | ± | – | – | – | HIV-1 positive |
140,058 | Africa | FR | FR | OK | OK | FR | FR | OK | OK | 302.00 | R | 2560 | R | Positive | 0.26 | NR | 0,85 | NR | 0.41 | NR | NT | Negative | ||||||
140,115 | Africa | FR | OK | FR | FR | OK | OK | OK | OK | 57.30 | R | 320 | R | Positive | 0.29 | NR | 0,31 | NR | 0.51 | NR | NT | Negative | ||||||
140,134 | Africa | FR | OK | FR | OK | OK | OK | OK | OK | 46.80 | R | 1280 | R | Positive | 0.31 | NR | 0,35 | NR | 0.47 | NR | NT | Negative |
Anti-TP detection component
WHO N° | Origin | INSTI Multiplex HIV-1/HIV-2/Syphilis antibody test | DPP HIV/Syphilis Assay | SD Bioline HIV/Syphilis Duo | Multiplo rapid TP/HIV Antibody test | Reference Results TP | Reference result for HIV | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vitros Syphilis TPA assay | TP particle agglutination (TTPA) | RPR | RecomLine Treponema IgM | Reference result for TP | |||||||||||||
Initial | Final | Initial | Final | Initial | Final | Initial | Final | S/CO | Result | Result | |||||||
Initial result not correct in all four RDTs | |||||||||||||||||
WHO3–0008 | South America | FN | FN | FN | FN | FN | FN | FN | FN | 11,60 | R | 160 | R | N | NT | Positive | Negative |
140,017 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 11,80 | R | 640 | R | N | NT | Positive | Negative |
140,020 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 8,50 | R | 320 | R | N | NT | Positive | Negative |
140,087 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 22,00 | R | 320 | R | N | NT | Positive | Negative |
140,127 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 20,90 | R | 320 | R | N | NT | Positive | Negative |
140,148 | Europe | FN | FN | FN | FN | FN | FN | FN | FN | 7,97 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,150 | Europe | FN | FN | FN | FN | FN | FN | FN | FN | 4,65 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,176 | Europe | FN | FN | FN | FN | FN | FN | FN | FN | 11,60 | R | 1280 | R | N | NT | Positive | HIV-1 positive |
140,179 | United States | FN | FN | FN | FN | FN | FN | FN | FN | 5,83 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,180 | Europe | FN | FN | FN | FN | FN | FN | FN | FN | 5,79 | R | 320 | R | N | NT | Positive | HIV-1 positive |
140,207 | Europe | FN | FN | FN | FN | FN | FN | FN | FN | 36,40 | R | 640 | R | N | NT | Positive | HIV-1 positive |
140,215 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 13,20 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,231 | Asia | FN | FN | FN | FN | FN | FN | FN | FN | 5,97 | R | 80 | R | N | NT | Positive | HIV-1 positive |
991,126 | Africa | FN | FN | FN | FN | FN | FN | FN | FN | 5,16 | R | 160 | R | N | NT | Positive | HIV-1 positive |
Initial result not correct in three RDTs and one indeterminate result | |||||||||||||||||
140,016 | Africa | FN | FN | FN | FN | IND | OK | FN | FN | 19,50 | R | 640 | R | N | NT | Positive | Negative |
140,037 | Africa | FN | FN | FN | FN | IND | OK | FN | FN | 44,40 | R | 640 | R | R | NT | Positive | Negative |
140,107 | Africa | FN | FN | FN | FN | IND | IND | FN | FN | 24,90 | R | 640 | R | N | NT | Positive | Negative |
140,109 | Africa | FN | FN | FN | FN | IND | IND | FN | FN | 18,30 | R | 320 | R | R | NT | Positive | Negative |
140,209 | Europe | FN | FN | FN | OK | IND | FN | FN | FN | 29,10 | R | 320 | R | N | NT | Positive | HIV-1 positive |
Initial result not correct in two RDTs and two indeterminate results | |||||||||||||||||
140,006 | Africa | FN | FN | IND | IND | IND | OK | FN | FN | 59,80 | R | 640 | R | N | NT | Positive | Negative |
140,170 | Europe | FN | FN | IND | FN | IND | OK | FN | FN | 14,40 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,208 | Europe | FN | FN | IND | FN | IND | OK | FN | FN | 40,90 | R | 640 | R | N | NT | Positive | HIV-1 positive |
Initial result not correct in tree RDTs | |||||||||||||||||
140,009 | Africa | FN | FN | FN | OK | OK | OK | FN | FN | 54,80 | R | 1280 | R | N | NT | Positive | Negative |
140,149 | Europe | OK | OK | FN | FN | FN | FN | FN | FN | 42,60 | R | 320 | R | N | NT | Positive | HIV-1 positive |
991,110 | Africa | FN | FN | FN | FN | FN | FN | OK | OK | 8,68 | R | 80 | R | N | NT | Positive | HIV-1 positive |
Initial result not correct in two RDTs and one indeterminate result | |||||||||||||||||
140,085 | Africa | FN | FN | IND | FN | OK | OK | FN | FN | 7,90 | R | 160 | R | N | NT | Positive | Negative |
140,091 | Africa | FN | FN | OK | OK | IND | IND | FN | IND | 31,50 | R | 640 | R | N | NT | Positive | Negative |
140,146 | Europe | FN | FN | IND | IND | OK | OK | FN | FN | 19,30 | R | 80 | R | N | NT | Positive | HIV-1 positive |
140,160 | Europe | OK | OK | IND | FN | FN | FN | FN | FN | 425,00 | R | 5120 | R | N | NT | Positive | HIV-1 positive |
140,167 | Europe | FN | FN | OK | OK | IND | FN | FN | FN | 27,10 | R | 640 | R | N | NT | Positive | HIV-1 positive |
140,192 | Europe | FN | FN | IND | OK | OK | OK | FN | FN | 15,00 | R | 320 | R | N | NT | Positive | HIV-1 positive |
Initial result not correct in two RDTs | |||||||||||||||||
140,056 | Africa | FN | FN | OK | OK | OK | OK | FN | FN | 33,00 | R | 640 | R | N | NT | Positive | Negative |
140,111 | Africa | FN | FN | OK | OK | OK | OK | FN | FN | 57,00 | R | 640 | R | N | NT | Positive | Negative |
140,133 | Africa | FN | FN | OK | OK | OK | OK | FN | IND | 61,40 | R | 640 | R | N | NT | Positive | Negative |
140,134 | Africa | FN | FN | OK | OK | OK | OK | FN | FN | 46,80 | R | 1280 | R | N | NT | Positive | Negative |
140,140 | Europe | FN | OK | OK | OK | OK | OK | FN | FN | 35,40 | R | 320 | R | N | NT | Positive | HIV-1 positive |
140,141 | Africa | FN | OK | OK | OK | OK | OK | FN | FN | 64,80 | R | 320 | R | N | NT | Positive | HIV-1 positive |
140,152 | Europe | FN | FN | OK | OK | OK | OK | FN | FN | 18,20 | R | 160 | R | N | NT | Positive | HIV-1 positive |
140,174 | Europe | FN | FN | OK | OK | OK | OK | IND | FN | 29,30 | R | 320 | R | R | NT | Positive | HIV-1 positive |
140,219 | Europe | FN | FN | OK | OK | OK | OK | FN | FN | 41,50 | R | 640 | R | N | NT | Positive | HIV-1 positive |
140,223 | Europe | FN | FN | OK | OK | OK | OK | FN | IND | 42,50 | R | 640 | R | N | NT | Positive | HIV-1 positive |
140,230 | South America | FN | FN | OK | OK | OK | OK | FN | FN | 53,60 | R | 320 | R | N | NT | Positive | HIV-1 positive |
WHO3–0586 | Africa | FR | FR | OK | OK | OK | OK | FR | FR | 0,02 | NR | – | NR | N | Negative | Negative | HIV-1 positive |
Commercial panels
SD Bioline HIV/Syphilis Duo | DPP HIV-Syphilis Assay | Multiplo Rapid TP/HIV Antibody Test | Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test | |
---|---|---|---|---|
HIV seroconversion panel | HIV-1/2 antibodies were detected 0.125 specimens earlier compared to the reference assay | HIV-1/2 antibodies were detected 0.25 specimens later compared to the reference assay | HIV-1/2 antibodies were detected 0.125 specimens later compared to the reference assay | HIV-1/2 antibodies were detected at the same time as the reference assay |
HIV mixed titre panels | All were correctly detected | 88% were correctly detected (22/25; one false reactive, one false non-reactive and one indeterminate) | 96% were correctly detected (24/25; one false non-reactive) | All were correctly detected |
WHO HIV Reference preparations | All were correctly detected, with the exception of the Group O specimen (indeterminate) | All were correctly detected | All were correctly detected | All were correctly detected |
TP seroconversion panels | TP antibodies were detected 2 specimens earlier compared to the reference assay | TP antibodies were detected at the same time compared to the reference assay | TP antibodies were detected 2 specimens later compared to the reference assay | TP antibodies were detected 1 specimen earlier compared to the reference assay |
TP mixed titre panels | All were correctly detected | All were correctly detected | All were correctly detected | All were correctly detected |
WHO TP Reference preparations | All were correctly detected | All were correctly detected | All were correctly detected | All were correctly detected |
Discussion
SD Bioline HIV/Syphilis Duo | DPP HIV-Syphilis Assay | Multiplo Rapid TP/HIV Antibody Test | Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test | |
---|---|---|---|---|
Antibodies to HIV | ||||
Sensitivity (%) | ||||
This evaluation (95% CI) | 100 (98.2–100) | 100 (98.2–100) | 99.5 (97.2–100) | 99.5 (97.2–100) |
Previous laboratory evaluationsa | 97.1–100 | 98.8–100 | 97.9–100 | 100 |
Previous field evaluationsa | 98.8–99.2 | NA | 93.8 | 93.8 |
Specificity (%) | ||||
This evaluation | 99.5 (97.2–100) | 97.5 (94.3–99.2) | 99.5 (97.2–100) | 93.5 (89.1–96.5) |
Previous laboratory evaluationsa | 99.5–100 | 97.9–98.7 | 91.9–98.3 | 95.5 |
Previous field evaluationsa | 97.0–100 | NA | 100 | 100 |
Antibodies to Treponema pallidum | ||||
Sensitivity (%) | ||||
This evaluation (95% CI) | 87.0 (81.5–91.3) | 86.5 (81.0–90.9) | 73.5 (66.8–79.5) | 81.0 (74.9–86.2) |
Previous laboratory evaluationsa | 72.2–100 | 82.5–98.8 | 80.7–94.6 | 87.4 |
Previous field evaluationsa | 66.7–96.5 | NA | 81 | 81.0 |
Specificity (%) | ||||
This evaluation | 99.5 (97.2–100) | 100 (98.2–100) | 99.5 (97.2–100) | 99.0 (96.4–99.9) |
Previous laboratory evaluationsa | 96.0–100 | 96.4–100 | 88.7–97.2 | 97.0 |
Previous field evaluationsa | 90.8–98.8 | NA | 100 | 100 |
Prevalence % | SD Bioline HIV/Syphilis Duo | DPP HIV-Syphilis Assay | Multiplo Rapid TP/HIV Antibody Test | Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test | ||||
---|---|---|---|---|---|---|---|---|
HIV | T pallidum | HIV | T pallidum | HIV | T pallidum | HIV | T pallidum | |
PPV | ||||||||
0.1 | 16.68 | 14.76 | 2.44 | 100 | 16.61 | 6.55 | 0.82 | 7.29 |
1 | 66.89 | 63.60 | 20.16 | 100 | 66.78 | 41.42 | 7.73 | 44.23 |
5 | 91.32 | 90.10 | 56.82 | 100 | 91.28 | 78.65 | 30.40 | 80.51 |
NPV | ||||||||
0.1 | 100 | 99.99 | 100 | 99.98 | 100 | 99.97 | 100 | 99.98 |
1 | 100 | 99.86 | 100 | 99.85 | 99.99 | 99.69 | 99.99 | 99.78 |
5 | 100 | 99.20 | 100 | 99.22 | 99.97 | 98.43 | 99.97 | 98.87 |