Table 4. Meta-analysis of clinical metrics overall and for each viral load technology and protocol for treatment failure thresholds below 1,000 copies/ml.
| All technologies | Abbott RealTime HIV-1 two-spot | Abbott RealTime HIV-1 one-spot | Biocentric Generic HIV Charge Virale | bioMerieux NucliSENS EasyQ HIV-1 | Hologic Aptima | Roche COBAS TaqMan HIV-1 FVE | Roche COBAS TaqMan HIV-1 SPEX | Siemens VERSANT HIV-1 RNA | ||
|---|---|---|---|---|---|---|---|---|---|---|
| n | 10,831 | 2,004 | 700 | 531 | 1,062 | 124 | 3,076 | 3,190 | 144 | |
| DBS:plasma threshold comparisons | ||||||||||
| Sensitivity (UCL-LCL) | 800:800 | 95.04 (91.45–97.17) | 92.59 (82.86–96.99) | 91.55 (4.60–99.96) | 98.64 (43.94–99.99) | 85.36 (80.27–89.32) | 93.47 (31.10–99.78) | 95.35 (87.11–98.42) | 99.70 (95.62–99.98) | 91.07 (74.87–97.22) |
| 600:600 | 95.24 (92.21–97.12) | 92.71 (84.14–96.83) | 92.95 (0.04–100.00) | 98.55 (60.16–99.97) | 88.87 (83.99–92.40) | 94.54 (27.75–99.87) | 94.17 (83.85–98.05) | 99.26 (96.03–99.87) | 93.45 (84.10–97.47) | |
| 500:500 | 95.43 (92.38–97.30) | 93.11 (84.49–97.11) | 92.96 (0.00–100.00) | 98.40 (66.61–99.95) | 89.04 (84.76–92.22) | 94.50 (29.45–99.86) | 93.37 (81.99–97.75) | 99.22 (95.81–99.86) | 97.21 (66.06–99.84) | |
| 400:400 | 95.51 (92.35–97.41) | 92.48 (84.11–96.61) | 94.36 (0.00–100.00) | 97.79 (60.28–99.92) | 90.17 (85.52–93.44) | 94.69 (28.03–99.88) | 92.26 (80.79–97.13) | 99.36 (95.26–99.92) | 97.18 (62.91–99.86) | |
| 200:200 | 94.78 (91.11–96.99) | 90.80 (82.55–95.37) | 97.18 (0.00–100.00) | 98.09 (65.21–99.93) | 89.42 (83.74–93.28) | 95.01 (22.04–99.92) | 89.86 (76.26–96.07) | 99.16 (94.75–99.87) | 97.67 (71.68–99.86) | |
| Detectable | 95.39 (90.12–97.91) | 92.81 (76.47–98.09) | 93.13 (62.76–99.09) | 97.98 (59.94–99.94) | 88.59 (75.29–95.18) | 75.42 (51.82–89.75) | 97.10 (58.02–99.88) | 99.76 (94.64–99.99) | 90.08 (83.66–94.15) | |
| Specificity (UCL-LCL) | 800:800 | 83.56 (71.57–91.12) | 92.01 (83.14–96.41) | 99.77 (23.66–100.00) | 38.14 (10.78–75.88) | 95.99 (91.31–98.20) | 72.16 (41.80–90.34) | 92.86 (64.86–98.92) | 37.59 (13.30–70.28) | 86.62 (68.28–95.11) |
| 600:600 | 82.52 (69.82–90.60) | 92.54 (81.42–97.23) | 99.77 (12.38–100.00) | 28.13 (5.97–70.70) | 95.21 (91.29–97.42) | 89.34 (50.48–98.57) | 92.95 (68.03–98.79) | 32.98 (11.54–64.98) | 78.77 (60.95–89.82) | |
| 500:500 | 80.41 (66.80–89.33) | 93.16 (81.96–97.61) | 99.77 (9.33–100.00) | 23.72 (4.28–68.41) | 95.27 (91.10–97.54) | 89.06 (50.38–98.49) | 91.71 (67.71–98.32) | 29.63 (9.78–62.04) | 65.63 (30.99–89.04) | |
| 400:400 | 79.81 (65.43–89.20) | 93.15 (80.02–97.88) | 99.77 (8.20–100.00) | 11.35 (0.61–72.77) | 95.61 (90.73–97.98) | 88.44 (47.82–98.46) | 92.04 (67.80–98.45) | 27.71 (9.04–59.65) | 64.91 (24.64–91.28) | |
| 200:200 | 81.57 (67.54–90.40) | 97.22 (91.66–99.11) | 99.78 (5.34–100.00) | 15.09 (1.30–70.49) | 92.94 (89.26–95.43) | 81.48 (71.52–88.52) | 91.60 (71.21–97.96) | 25.31 (7.60–58.26) | 64.68 (26.23–90.41) | |
| Detectable | 60.98 (34.29–82.40) | 78.79 (8.46–99.33) | 93.16 (66.40–98.94) | 18.62 (4.87–50.58) | 93.46 (90.43–95.59) | 87.18 (66.58–95.87) | 58.09 (6.37–96.58) | 4.25 (0.17–53.54) | 69.23 (40.93–87.96) | |
| Total misclassification (UCL-LCL) | 800:800 | 9.97 (6.92–14.15) | 8.39 (5.26–13.11) | 0.23 (0.00–78.78) | 11.96 (1.98–47.79) | 9.03 (6.80–11.91) | 18.55 (12.65–26.37) | 10.35 (5.77–17.89) | 22.44 (11.82–38.44) | 10.39 (4.12–23.82) |
| 600:600 | 9.12 (6.16–13.30) | 8.04 (5.01–12.67) | 0.23 (0.00–84.65) | 12.85 (1.95–52.18) | 7.78 (5.64–10.64) | 6.67 (0.54–48.42) | 10.42 (6.16–17.09) | 23.81 (12.52–40.57) | 11.11 (6.92–17.37) | |
| 500:500 | 9.21 (6.15–13.58) | 7.72 (4.78–12.24) | 0.23 (0.00–87.30) | 10.79 (1.09–57.09) | 7.82 (5.72–10.61) | 6.67 (0.54–48.43) | 11.03 (7.08–16.79) | 25.00 (13.21–42.19) | 13.19 (8.58–19.76) | |
| 400:400 | 8.87 (5.80–13.35) | 7.94 (5.04–12.29) | 0.23 (0.00–87.36) | 9.40 (0.62–63.44) | 7.50 (5.25–10.62) | 6.55 (0.49–50.14) | 10.95 (7.18–16.33) | 25.35 (13.21–43.11) | 13.19 (8.58–19.76) | |
| 200:200 | 8.04 (4.99–12.70) | 7.13 (4.11–12.08) | 0.23 (0.00–88.53) | 4.33 (0.08–73.07) | 8.94 (6.41–12.34) | 6.23 (0.25–63.87) | 11.01 (7.52–15.83) | 24.02 (12.02–42.26) | 10.42 (6.38–16.56) | |
| Detectable | 8.73 (5.22–14.24) | 9.64 (4.17–20.74) | 15.00 (12.54–17.84) | 4.65 (0.07–76.18) | 11.26 (6.16–19.71) | 20.97 (14.69–29.02) | 7.29 (1.41–30.10) | 8.26 (2.36–25.14) | 11.81 (7.47–18.17) | |
| Upward misclassification (UCL-LCL) | 800:800 | 16.44 (8.88–28.43) | 7.99 (3.59–16.86) | 0.23 (0.00–76.34) | 61.86 (24.12–89.22) | 4.01 (1.80–8.69) | 27.84 (9.66–58.20) | 7.14 (1.08–35.14) | 62.41 (29.72–86.70) | 13.38 (4.89–31.72) |
| 600:600 | 17.48 (9.40–30.18) | 7.46 (2.77–18.58) | 0.23 (0.00–87.62) | 71.87 (29.30–94.03) | 4.79 (2.58–8.71) | 10.66 (1.43–49.52) | 7.05 (1.21–31.97) | 67.02 (35.02–88.46) | 21.23 (10.18–39.05) | |
| 500:500 | 19.59 (10.67–33.20) | 6.84 (2.39–18.04) | 0.23 (0.00–90.67) | 76.28 (31.59–95.72) | 4.73 (2.46–8.90) | 10.94 (1.51–49.62) | 8.29 (1.68–32.29) | 70.37 (37.96–90.22) | 34.37 (10.96–69.01) | |
| 400:400 | 20.19 (10.80–34.57) | 6.85 (2.12–19.98) | 0.23 (0.00–91.80) | 88.65 (27.23–99.39) | 4.39 (2.02–9.27) | 11.56 (1.54–52.18) | 7.96 (1.55–32.20) | 72.29 (40.35–90.96) | 35.09 (8.72–75.36) | |
| 200:200 | 18.43 (9.60–32.46) | 2.78 (0.89–8.34) | 0.22 (0.00–94.66) | 84.91 (29.51–98.70) | 7.06 (4.57–10.74) | 18.52 (11.48–28.48) | 8.40 (2.04–28.79) | 74.69 (41.74–92.40) | 35.32 (9.59–73.77) | |
| Detectable | 39.02 (17.60–65.71) | 21.21 (0.67–91.54) | 6.84 (1.06–33.60) | 81.38 (49.42–95.13) | 6.54 (4.41–9.57) | 12.82 (4.13–33.42) | 41.91 (3.42–93.63) | 95.75 (46.46–99.83) | 30.77 (12.04–59.07) | |
| Downward misclassification (UCL-LCL) | 800:800 | 4.96 (2.83–8.55) | 7.41 (3.01–17.14) | 8.45 (0.04–95.40) | 1.36 (0.01–56.06) | 14.64 (10.68–19.73) | 6.53 (0.22–68.90) | 4.65 (1.58–12.89) | 0.30 (0.02–4.38) | 8.93 (2.78–25.13) |
| 600:600 | 4.76 (2.88–7.79) | 7.29 (3.17–15.86) | 7.05 (0.00–99.96) | 1.45 (0.03–39.84) | 11.13 (7.60–16.01) | 5.46 (0.13–72.25) | 5.83 (1.95–16.15) | 0.74 (0.13–3.97) | 6.55 (2.53–15.90) | |
| 500:500 | 4.57 (2.70–7.62) | 6.89 (2.89–15.51) | 7.04 (0.00–100.00) | 1.60 (0.05–33.39) | 10.96 (7.78–15.24) | 5.50 (0.14–70.55) | 6.63 (2.25–18.01) | 0.78 (0.14–4.19) | 2.79 (0.16–33.94) | |
| 400:400 | 4.49 (2.59–7.65) | 7.52 (3.39–15.89) | 5.64 (0.00–100.00) | 2.21 (0.08–39.72) | 9.83 (6.56–14.48) | 5.31 (0.12–71.97) | 7.74 (2.87–19.21) | 0.64 (0.08–4.74) | 2.82 (0.14–37.09) | |
| 200:200 | 5.22 (3.01–8.89) | 9.20 (4.63–17.45) | 2.82 (0.00–100.00) | 1.91 (0.07–34.79) | 10.58 (6.72–16.26) | 4.99 (0.08–77.96) | 10.14 (3.93–23.74) | 0.84 (0.13–5.25) | 2.33 (0.14–28.32) | |
| Detectable | 4.61 (2.09–9.88) | 7.19 (1.91–23.53) | 6.87 (0.91–37.24) | 2.02 (0.06–40.06) | 11.41 (4.82–24.71) | 24.58 (10.25–48.18) | 2.90 (0.12–41.98) | 0.24 (0.01–5.36) | 9.92 (5.85–16.34) | |
| PPV (UCL-LCL) | 800:800 | 89.22 (82.88–93.40) | 93.43 (88.98–96.16) | 86.67 (11.76–99.69) | 88.79 (50.70–98.39) | 96.91 (93.16–98.64) | 63.04 (48.39–75.64) | 87.09 (66.28–95.86) | 67.49 (40.14–86.53) | 93.44 (82.58–97.71) |
| 600:600 | 89.74 (83.48–93.80) | 94.46 (89.47–97.16) | 82.50 (13.38–99.31) | 88.64 (48.24–98.49) | 96.13 (91.82–98.21) | 93.68 (8.52–99.96) | 89.28 (68.33–96.98) | 66.39 (38.39–86.23) | 91.18 (83.90–95.35) | |
| 500:500 | 89.50 (83.10–93.66) | 95.13 (89.88–97.73) | 80.49 (31.57–97.36) | 90.95 (47.06–99.13) | 96.08 (91.90–98.14) | 93.66 (9.34–99.95) | 87.39 (69.63–95.44) | 66.21 (37.81–86.33) | 88.75 (78.93–94.33) | |
| 400:400 | 90.26 (83.87–94.29) | 95.37 (90.57–97.79) | 79.76 (21.07–98.31) | 92.82 (45.93–99.49) | 96.25 (96.23–96.26) | 93.67 (8.17–99.96) | 86.58 (72.16–94.13) | 66.90 (37.97–86.96) | 89.88 (78.90–95.47) | |
| 200:200 | 93.09 (86.54–96.58) | 99.14 (93.84–99.89) | 77.53 (66.60–85.65) | 96.79 (38.29–99.93) | 95.31 (90.04–97.86) | 93.81 (7.53–99.96) | 87.80 (75.05–94.51) | 70.56 (39.94–89.62) | 92.17 (85.64–95.88) | |
| Detectable | 97.60 (94.45–98.98) | 99.69 (91.78–99.99) | 93.25 (53.87–99.39) | 96.80 (38.43–99.93) | 96.51 (93.13–98.26) | 93.69 (35.94–99.75) | 98.07 (90.92–99.61) | 92.19 (70.22–98.34) | 98.67 (65.40–99.97) | |
| NPV (UCL-LCL) | 800:800 | 92.83 (87.27–96.07) | 90.48 (79.65–95.85) | 99.77 (48.10–100.00) | 33.65 (1.43–94.65) | 79.41 (62.31–90.00) | 92.31 (83.92–96.50) | 97.39 (94.33–98.82) | 97.53 (94.81–98.84) | 78.00 (64.49–87.38) |
| 600:600 | 92.44 (87.13–95.67) | 89.59 (77.67–95.52) | 99.77 (56.44–100.00) | 41.43 (3.28–93.66) | 83.11 (64.24–93.09) | 97.05 (31.73–99.96) | 96.66 (92.95–98.45) | 96.85 (93.97–98.38) | 83.33 (68.95–91.84) | |
| 500:500 | 92.27 (86.93–95.55) | 89.73 (79.34–95.21) | 99.77 (55.62–100.00) | 34.65 (2.09–92.93) | 83.19 (65.11–92.92) | 97.00 (32.11–99.95) | 95.92 (91.92–97.98) | 96.20 (92.60–98.08) | 83.39 (53.74–95.60) | |
| 400:400 | 91.83 (85.88–95.41) | 88.15 (75.52–94.72) | 99.77 (67.05–100.00) | 26.51 (2.48–83.67) | 84.74 (70.14–92.92) | 93.24 (84.77–97.16) | 94.71 (89.03–97.53) | 95.21 (90.77–97.57) | 81.23 (49.15–95.09) | |
| 200:200 | 87.86 (80.59–92.66) | 82.53 (71.11–90.07) | 99.79 (91.24–100.00) | 14.76 (0.24–92.55) | 79.75 (63.92–89.74) | 96.57 (27.65–99.95) | 92.24 (84.69–96.23) | 93.38 (85.67–97.08) | 79.31 (60.95–90.40) | |
| Detectable | 57.74 (41.04–72.84) | 58.92 (35.49–78.90) | 93.33 (50.20–99.49) | 3.19 (0.01–95.43) | 63.22 (33.93–85.19) | 68.34 (38.97–87.94) | 52.90 (27.86–76.57) | 72.19 (36.12–92.26) | 21.12 (0.86–89.25) |