Table 4.
Detailed testing results of false-negative and false-positive misdiagnosed participants at site.
| Study site | Sample ID | Test result on site | Status on site | ELISA results reference laboratory | LIA results reference laboratory | Status by reference laboratory | Remarks |
|---|---|---|---|---|---|---|---|
| False-negative misdiagnosed participants | |||||||
| Kitgum | 196 | Determine: reactive Uni-Gold: non-reactive Stat-Pak: non-reactive |
HIV negative* | OD: 1.766 CO: 0.161 OD/CO: 10.97 Result: reactive |
sgp120: − gp41: 1+ p31: − p24:1+ p17:2+ |
HIV positive | No backup sample |
| Arua | 368 | Determine: non-reactive | HIV negative | OD: 3.000 CO: 0.179 OD/CO: ≥16.76 Result: reactive |
sgp120: 2+ gp41: 3+ p31: 2+ p24: 3+ p17: 3+ sgp105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Stat-Pak: reactive Uni-Gold: reactive |
| Arua | 453 | Determine: non-reactive | HIV negative | OD: 3.000 CO: 0.186 OD/CO: ≥16.13 Result: reactive |
sgp120: 2+ gp41: 4+ p31: − p24: 4+ p17: 4+ sgp105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Stat-Pak: reactive Uni-Gold: reactive |
| Arua | 454 | Determine: non-reactive | HIV negative | OD: 3.000 CO: 0.186 OD/CO: ≥16.13 Result: reactive |
sgp120: 2+ gp41: 4+ p31:3+ p24: 3+ p17: − sgp105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Stat-Pak: reactive Uni-Gold: reactive |
| Arua | 611 | Determine: non-reactive | HIV negative | OD: 3.000 CO: 0.173 OD/CO: ≥17.34 Result: reactive |
sgp120: 2+ gp41: 3+ p31: − p24: 3+ p17: 2+ sgp105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Stat-Pak: non-reactive Uni-Gold: reactive |
| Homa-Bay | 394 | Determine: non-reactive Uni-Gold: non-reactive |
HIV negative | OD: 3.000 CO: 0.162 OD/CO: 18.52 Result: reactive |
sgp120: 3+ gp41: 3+ p31: 2+ p24: 3+ p17: 3+ sgp105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Uni-Gold: reactive |
| Homa-Bay | 439 | Determine: non-reactive Uni-Gold: non-reactive |
HIV negative | OD: 3.000 CO: 0.162 OD/CO: 18.52 Result: reactive |
spg120: 2+ gp41: 3+ p31: 2+ p24: 4+ p17: 3+ spg105: − gp36: − |
HIV-1 positive | Backup sample: Determine: reactive Uni-Gold: reactive |
| Homa-Bay | 469 | Determine: non-reactive Uni-Gold: non-reactive |
HIV negative | OD: 3.000 CO: 0.162 OD/CO: 18.52 Result: reactive |
spg120: 2+ gp41: 3+ p31: − p24: 3+ p17: 3+ spg105: − gp36: − |
HIV-1 positive | No backup sample |
| False-positive misdiagnosed participants | |||||||
| Kitgum | 240 | Determine: reactive Uni-Gold: reactive ImmunoComb CombFirm: reactive (p24+, p31+, gp120+, gp41+, p31−, gp36−) |
HIV positive | OD: 0.06 CO: 0.174 OD/CO: 0.34 Result: non-reactive |
– | HIV negative | No backup sample |
| Kitgum | 596 | Determine: reactive Uni-Gold: reactive ImmunoComb CombFirm: reactive (p24+, gp120 +, gp41+, p31−, gp36−) |
HIV-positive | OD: 0.066 CO: 0.180 OD/CO: 0.37 Result: non-reactive |
– | HIV negative | No backup sample |
| Arua | 342 | Determine: reactive Stat-Pak: reactive |
HIV positive | OD: 0.049 CO: 0.179 OD/CO: 0.27 Result: non-reactive |
– | HIV negative | Backup sample: Determine: reactive Stat-Pak: non-reactive Uni-Gold: non-reactive |
| Arua | 529 | Determine: reactive Stat-Pak: reactive |
HIV positive | OD: 0.057 CO: 0.170 OD/CO: 0.34 Result: non-reactive |
– | HIV negative | Backup sample: Determine: reactive Stat-Pak: reactive Uni-Gold: non-reactive |
| Arua | 622 | Determine: reactive Stat-Pak: reactive |
HIV positive | OD: 0.067 CO: 0.173 OD/CO: 0.39 Result: non-reactive |
– | HIV negative | Backup sample: Determine: reactive Stat-Pak: non-reactive Uni-Gold: non-reactive |
| Homa-Bay | 5 | Determine: reactive Uni-Gold: non-reactive EIA GS: reactive |
HIV positive | OD: 0.084 CO: 0.261 OD/CO: 0.32 Result: non-reactive |
– | HIV negative | Backup sample: Determine: reactive Uni-Gold: non-reactive |
| Homa-Bay | 16 | Determine: reactive Uni-Gold: reactive |
HIV positive | OD: 0.119 CO: 0.261 OD/CO: 0.46 Result: non-reactive |
– | HIV negative | Backup sample: Determine: reactive Uni-Gold: reactive The ELISA test at CDC in Kisumu was negative on the same sample. In addition, a western blot (GS HIV-1 Western Blot, No. 32508, Bio-Rad, USA) was carried out at CDC and had an indeterminate result: gp160+, gp120−, p65−, p55/51−, gp41−, p40+, p31+/−, p24−, p18− |
| Douala | 48 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.043 CO: 0.153 OD/CO: 0.28 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. three months later was collected: Determine: reactive BiSpot: non-reactive ELISA at reference laboratory: non-reactive |
| Douala | 68 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.050 CO: 0.153 OD/CO: 0.33 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. three months later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: non-reactive |
| Douala | 307 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.053 CO: 0.154 OD/CO: 0.34 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. two months later was collected: Determine: non-reactive ELISA at reference laboratory: non-reactive |
| Douala | 356 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.058 CO: 0.166 OD/CO: 0.35 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. three months later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: non-reactive |
| Douala | 381 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.055 CO: 0.166 OD/CO: 0.33 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing. Second sample approx. 6 weeks later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: non-reactive |
| Douala | 411 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.048 CO: 0.154 OD/CO: 0.31 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. two months later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: non-reactive |
| Douala | 445 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 3.122 CO: 0.154 OD/CO: 20.27 Result: reactive |
sgp120: − gp41: 2+ p31: − p24: − p17: − sgp105: − gp36: − Innotest: non-reactive |
HIV negative | Backup sample same result as initial testing Second sample approx. 6 weeks later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: reactive INNO-LIA: sgp120: −, gp41: 2+, p31: −, p24: −, p17: −, sgp105: −, gp36: − Innotest: non-reactive |
| Douala | 464 | Determine: reactive BiSpot: reactive |
HIV positive | OD: 0.060 CO: 0.154 OD/CO: 0.39 Result: non-reactive |
– | HIV negative | Backup sample same result as initial testing Second sample approx. 4 weeks later was collected: Determine: reactive BiSpot: reactive ELISA at reference laboratory: non-reactive |
| Baraka | 479 | Determine: reactive Uni-Gold: reactive (both on capillary whole blood and plasma) ImmunoComb CombFirm: reactive (p24+, p31−, gp120+, gp41+, p31−, gp36−) |
HIV positive | OD: 0.048 CO: 0.149 OD/CO: 0.32 Result: non-reactive |
– | HIV negative | No backup sample |
*HIV negative by Ministry of Health algorithm and inconclusive by alternative Médecins sans Frontières algorithm.
CO: Cutoff; OD: optical density; Determine: Determine HIV-1/2 (Alere, USA); Uni-Gold: Uni-Gold HIV (Trinity Biotech, Ireland); Stat-Pak: HIV 1/2 Stat-Pak (Chembio, USA); ImmunoComb CombFirm = ImmunoComb CombFirm II HIV 1&2 CombFirm (Orgenics, Alere, Israel); EIA GS: GS HIV-1/HIV-2 PLUS O EIA (Bio-Rad, USA); BiSpot: ImmunoComb CombFirm II HIV 1&2 BiSpot (Orgenics, Alere, Israel).