Table 2: Comparison of The COBAS Ampliprep/COBAS Taqman HIV-1 Test v2 (Standard assay) with an ultra-centrifugation step prior to the standard protocol (Ultrasensitive assay) in two separate dilution series (Panel 1 and 2). Input copies/ml are theoretical concentrations calculated from a dilution series originated from a plasma sample quantified by COBAS Ampliprep/COBAS Taqman HIV-1 Test, version 2. All samples were run in quadruplicate (1-4), once in each dilution step.

Panel 1 Standard assay Ultrasensitive assay
Input copies/ml 1 2 3 4 Mean copies/ml SD CV 1 2 3 4 Mean copies/ml SD CV
2683 3284 2332 3599 3915 3283 684 21 1942 1862 1257 1639 1675 307 18 %
537 686 660 572 637 639 47 8 % 554 607 459 148 442 205 46 %
107 130 126 132 84 118 23 19 94 52 61 - 69 22 32 %
26.8 < 20 < 20 23 < 20 - - 24 47 20 13 26 15 57 %
5.4 < 20 - 30 < 20 - - 5.4 6.2 5.6 - 5.7 0.4 7 %
2.7 < 20 - - < 20 - - Det Det 6.1 Det - -

Panel 2 Standard assay Ultrasensitive assay
Input copies/ml 1 2 3 4 Mean copies/ml SD CV 1 2 3 4 Mean copies/ml SD CV
27 50 36 200 78 91 75 82 % 103 105 104 59 93 23 % 24 %
9 < 20 44 < 20 29 36.5 11 29% 32 27 43 24 31 8.3 27%
3 - - - < 20 - 14 5.1 7 8.7 4.7 54%
1 - - - - 3.2 - 2.1 2.2 2.5 0.6 24%

SD: Standard Deviation; CV: Coefficient of Variation; Det: Detected but not quantified by the ultrasensitive assay; < 20: Detected but not quantified by the standard assay (The COBAS Taqman HIV-1 test, version 2.0 from Roche).