Table 3.
Meta-analysis of clinical metrics (median viral loads, mean bias, sensitivity, specificity, and misclassification) overall and for each comparator technology, across various treatment failure thresholds.
| Comparator used | |||||
|---|---|---|---|---|---|
| All together | Abbott RealTime HIV-1 | bioMerieux NucliSENS EasyQ HIV-1 |
Roche COBAS TaqMan HIV-1 |
||
| n | 3,790 | 1,981 | 376 | 1,433 | |
| Cepheid Xpert | |||||
| median viral load (copies/ml) | 119 | 188 | 39 | 63 | |
| Comparator | |||||
| median viral load (copies/ml) | 157 | 219 | 1 | 133 | |
| difference in medians (copies/ml) | −38 | −31 | 38 | −70 | |
| mean bias (log copies/ml) | 0.04 (0.02-0.07) | 0.11 (0.07-0.14) | 0.16 (0.10-0.22) | −0.08 (−0.11- −0.04) | |
| Threshold comparisons | |||||
| Sensitivity (UCL-LCL) | 1000:1000 | 96.47 (95.10-97.47) | 95.86 (93.59-97.35) | 99.10 (95.07-99.95) | 96.56 (94.54-97.85) |
| 800:800 | 96.92 (95.80-97.75) | 96.96 (95.27-98.06) | 98.26 (93.88-99.52) | 96.66 (94.58-97.96) | |
| 600:600 | 96.86 (95.74-97.69) | 97.24 (95.82-98.19) | 97.54 (93.02-99.16) | 95.71 (95.70-95.73) | |
| 500:500 | 96.74 (95.60-97.59) | 96.82 (95.41-97.80) | 97.58 (93.13-99.17) | 96.44 (94.05-97.89) | |
| 400:400 | 96.04 (94.80-96.98) | 96.24 (94.73-97.33) | 95.28 (90.08-97.82) | 95.61 (92.51-97.47) | |
| 200:200 | 95.36 (93.37-96.77) | 95.12 (92.92-96.66) | 91.16 (85.46-94.76) | 96.20 (90.71-98.50) | |
| detectable | 93.33 (88.24-96.31) | 95.92 (91.41-98.12) | 96.13 (92.23-98.11) | 88.42 (75.29-95.03) | |
| Specificity (UCL-LCL) | 1000:1000 | 96.59 (92.90-98.39) | 94.18 (86.10-97.69) | 97.36 (94.65-98.71) | 98.22 (94.68-99.42) |
| 800:800 | 96.75 (92.58-98.61) | 94.23 (82.60-98.25) | 96.93 (94.07-98.44) | 98.22 (95.24-99.34) | |
| 600:600 | 95.88 (91.86-97.96) | 92.98 (84.68-96.94) | 97.64 (94.94-98.91) | 98.03 (98.03-98.04) | |
| 500:500 | 95.35 (90.22-97.85) | 92.06 (81.55-96.82) | 97.62 (94.90-98.90) | 97.61 (92.83-99.23) | |
| 400:400 | 96.00 (92.66-97.86) | 94.91 (89.73-97.55) | 94.78 (91.27-96.92) | 97.95 (93.60-99.36) | |
| 200:200 | 97.69 (94.56-99.04) | 96.24 (89.71-98.68) | 96.51 (93.26-98.22) | 98.63 (94.23-99.69) | |
| detectable | 80.56 (64.63-90.39) | 69.31 (40.83-88.09) | 86.15 (80.60-90.31) | 83.02 (66.46-92.34) | |
| Total Misclassification (UCL-LCL) | 1000:1000 | 3.53 (2.52-4.93) | 4.69 (3.13-6.96) | 2.13 (1.08-4.14) | 2.67 (1.73-4.10) |
| 800:800 | 3.13 (2.22-4.41) | 3.97 (2.53-6.16) | 2.66 (1.45-4.83) | 2.53 (1.61-3.94) | |
| 600:600 | 3.58 (2.67-4.79) | 4.30 (2.95-6.23) | 2.39 (1.26-4.49) | 3.15 (2.08-4.74) | |
| 500:500 | 3.84 (2.90-5.06) | 4.66 (3.26-6.63) | 2.39 (1.26-4.49) | 3.21 (2.21-4.65) | |
| 400:400 | 3.91 (2.98-5.12) | 4.15 (2.74-6.26) | 5.05 (3.26-7.76) | 3.29 (2.47-4.37) | |
| 200:200 | 3.78 (2.63-5.41) | 4.55 (2.86-7.17) | 5.59 (3.68-8.39) | 2.85 (1.78-4.54) | |
| detectable | 11.19 (6.59-18.36) | 11.76 (5.49-23.42) | 9.04 (6.54-12.37) | 12.74 (5.69-26.11) | |
| Upward Misclassification (UCL-LCL) | 1000:1000 | 3.41 (1.61-7.10) | 5.82 (2.31-13.90) | 2.64 (1.29-5.35) | 1.78 (0.58-5.32) |
| 800:800 | 3.25 (1.39-7.42) | 5.77 (1.75-17.40) | 3.07 (1.56-5.93) | 1.78 (0.66-4.76) | |
| 600:600 | 4.12 (2.04-8.14) | 7.02 (3.06-15.32) | 2.36 (1.09-5.06) | 1.97 (1.96-1.97) | |
| 500:500 | 4.65 (2.15-9.78) | 7.94 (3.18-18.45) | 2.38 (1.10-5.10) | 2.39 (0.77-7.17) | |
| 400:400 | 4.00 (2.14-7.34) | 5.09 (2.45-10.27) | 5.22 (3.08-8.73) | 2.05 (0.64-6.40) | |
| 200:200 | 2.31 (0.96-5.44) | 3.76 (1.32-10.29) | 3.49 (1.78-6.74) | 1.37 (0.31-5.77) | |
| detectable | 19.44 (9.61-35.37) | 30.69 (11.91-59.17) | 13.85 (9.69-19.40) | 16.98 (7.66-33.54) | |
| Downward Misclassification (UCL-LCL) | 1000:1000 | 3.53 (2.53-4.90) | 4.14 (2.65-6.41) | 0.90 (0.05-4.93) | 3.44 (2.15-5.46) |
| 800:800 | 3.08 (2.25-4.20) | 3.04 (1.94-4.73) | 1.74 (0.48-6.12) | 3.34 (2.04-5.42) | |
| 600:600 | 3.14 (2.31-4.26) | 2.76 (1.81-4.18) | 2.46 (0.84-6.98) | 4.29 (4.27-4.30) | |
| 500:500 | 3.26 (2.41-4.40) | 3.18 (2.20-4.59) | 2.42 (0.83-6.87) | 3.56 (2.11-5.95) | |
| 400:400 | 3.96 (3.02-5.20) | 3.76 (2.67-5.27) | 4.72 (2.18-9.92) | 4.39 (2.53-7.49) | |
| 200:200 | 4.64 (3.23-6.63) | 4.88 (3.34-7.08) | 8.84 (5.24-14.54) | 3.80 (1.50-9.29) | |
| detectable | 6.67 (3.69-11.76) | 4.08 (1.88-8.59) | 3.87 (1.89-7.77) | 11.58 (4.97-24.71) | |
| PPV (UCL-LCL) | 1000:1000 | 95.37 (92.07-97.33) | 93.29 (87.10-96.63) | 94.02 (88.16-97.07) | 97.17 (93.19-98.86) |
| 800:800 | 96.04 (92.83-97.85) | 94.43 (87.89-97.54) | 93.39 (87.49-96.61) | 97.50 (93.80-99.02) | |
| 600:600 | 95.40 (92.24-97.31) | 93.45 (87.35-96.72) | 95.20 (89.92-97.78) | 97.19 (93.17-98.87) | |
| 500:500 | 95.25 (91.93-97.24) | 93.25 (86.85-96.65) | 95.28 (90.08-97.82) | 96.78 (91.68-98.79) | |
| 400:400 | 95.97 (92.84-97.77) | 95.30 (88.40-98.18) | 90.30 (84.11-94.24) | 97.35 (95.00-98.62) | |
| 200:200 | 98.00 (95.03-99.21) | 97.88 (89.24-99.61) | 94.37 (89.28-97.12) | 98.34 (95.10-99.45) | |
| detectable | 96.19 (89.68-98.65) | 94.24 (78.74-98.64) | 86.57 (81.16-90.60) | 97.12 (90.04-99.21) | |
| NPV (UCL-LCL) | 1000:1000 | 97.66 (94.83-98.96) | 97.96 (88.62-99.66) | 99.61 (97.85-99.98) | 97.53 (96.12-98.44) |
| 800:800 | 97.85 (96.51-98.69) | 97.89 (95.01-99.12) | 99.22 (97.19-99.78) | 97.46 (96.02-98.39) | |
| 600:600 | 97.51 (96.22-98.37) | 97.82 (91.92-99.44) | 98.80 (96.55-99.59) | 96.63 (94.85-97.81) | |
| 500:500 | 97.25 (95.53-98.32) | 97.28 (86.95-99.48) | 98.80 (96.52-99.59) | 96.82 (95.33-97.84) | |
| 400:400 | 96.56 (94.53-97.86) | 96.60 (84.57-99.33) | 97.52 (94.70-98.86) | 96.21 (94.41-97.45) | |
| 200:200 | 95.32 (94.02-96.35) | 94.09 (87.27-97.37) | 94.44 (90.73-96.72) | 96.28 (94.26-97.60) | |
| detectable | 69.76 (41.88-88.08) | 78.08 (46.47-93.60) | 96.00 (91.97-98.05) | 55.28 (14.32-90.14) | |
UCL: upper confidence level
LCL: lower confidence level