TABLE 1.
Within-run, interrun and interlaboratory reproducibility of Nuclisens HIV-1 QT for quantitation of high, low, and very low HIV-1 RNA levels in spiked plasma specimensa
| Comparison | Mean HIV-1 RNA level ± SD (CV [%])
|
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Laboratory 1
|
Laboratory 2
|
|||||||||||
| Specimen A
|
Specimen B
|
Specimen C
|
Specimen A
|
Specimen B
|
Specimen C
|
|||||||
| Copies/ml | Log copies/ml | Copies/ml | Log copies/ml | Copies/ml | Log copies/ml | Copies/ml | Log copies/ml | Copies/ml | Log copies/ml | Copies/ml | Log copies/ml | |
| Within run | ||||||||||||
| 1 | 430,000 ± 86,281 (20.1) |
5.62 ± 0.09 (1.7) |
2,540 ± 935 (36.8) |
3.38 ± 0.14 (4.3) |
267 ± 276 (103.3) |
2.28 ± 0.35 (15.2) |
451,000 ± 105,034 (23.3) |
5.64 ± 0.09 (1.7) |
2,910 ± 806 (27.7) |
3.45 ± 0.13 (3.9) |
310 ± 132 (42.7) |
2.44 ± 0.23 (9.4) |
| 2 | 521,000 ± 78,095 (15.0) |
5.71 ± 0.06 (1.1) |
2,070 ± 552 (26.7) |
3.30 ± 0.13 (3.8) |
355 ± 318 (89.7) |
2.45 ± 0.29 (11.7) |
410,000 ± 94,163 (23.0) |
5.60 ± 0.10 (1.7) |
2,520 ± 473 (18.8) |
3.39 ± 0.08 (2.3) |
365 ± 203 (55.7) |
2.51 ± 0.21 (8.3) |
| 3 | 424,000 ± 55,817 (13.2) |
5.62 ± 0.05 (1.0) |
2,030 ± 427 (21.0) |
3.30 ± 0.10 (2.9) |
300 ± 194 (64.6) |
2.39 ± 0.29 (12.0) |
579,000 ± 137,877 (23.8) |
5.75 ± 0.13 (2.3) |
2,510 ± 273 (10.9) |
3.40 ± 0.05 (1.3) |
692 ± 464 (67.1) |
2.77 ± 0.23 (8.4) |
| Between II runs | 458,333 ± 84,897 (19.0) |
5.65 ± 0.08 (1.4) |
2,213 ± 691 (31.0) |
3.33 ± 0.13 (3.8) |
307 ± 261 (85.0) |
2.38 ± 0.31 (12.9) |
480,000 ± 132,040 (28.0) |
5.67 ± 0.12 (2.1) |
2,647 ± 575 (22.0) |
3.41 ± 0.09 (2.8) |
456 ± 339 (74.0) |
2.58 ± 0.26 (10.1) |
| Between laboratories | 469,167 ± 110,596 (24.0) |
5.66 ± 0.10 (1.8) |
2,430 ± 667 (27.0) |
3.37 ± 0.12 (3.5) |
381 ± 309 (81.0) |
2.48 ± 0.30 (12.1) |
||||||
a
Specimens: A, high HIV-1 RNA level; B, low HIV-1 RNA level; C, very low HIV-1 RNA level.