Table 4.
Details of specimens discrepant from the TP reference result in two or more assays
| 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 |
ITG specimens obtained through the ITM clinic; FR false reactive, FN false non-reactive, OK result is concordant with the reference result, IND indeterminate result, S/CO sample signal/cut-off, OD/CO optical density/cut-off, R reactive, NR non-reactive, NT not tested, N negative