TABLE 1.
Limit of detection for the ultrasensitive and standard HIV-1 MONITOR Testsa
| Actual input concn (copies/ml) | No. of replicates | Standard test
|
Ultrasensitive test
|
||
|---|---|---|---|---|---|
| No. (%) positive | Avg no. of copies/mlb | No. (%) positive | Avg no. of copies/mlb | ||
| 1,000 | 3 | 3 (100) | 1,213 | 3 (100) | 1,190 |
| 500 | 3 | 3 (100) | 697 | 3 (100) | 612 |
| 100 | 6 | 2 (33) | 265 | 6 (100) | 134 |
| 50 | 7 | 1 (14) | 390 | 7 (100) | 67 |
| 40 | 7 | 2 (29) | 271 | 6 (86) | 90 |
| 30 | 7 | 0 (0) | Not detected | 7 (100) | 61 |
| 20 | 7 | 0 (0) | Not detected | 5 (71) | 55 |
| 0 | 6 | 0 (0) | Not detected | 0 (0) | Not detected |
a
The limit of detection was determined by using the ultra-low-level HIV RNA proficiency panel described in Materials and Methods.
b
The viral RNA concentration in each replicate reaction yielding a positive signal was calculated as described in Materials and Methods. The values presented here are the averages of the individual values for the positive replicates. Reactions yielding negative results were not included in the average.