CREATING CONFIDENCE
ANALYTICAL SENSITIVITY PANELS FOR HIV-RNA ASSAYS
In the mid1990s we established tissue culture HIV-1 RNA standards of different subtypes, which have been used in the international VQC proficiency program until 2004. The VQC-Sanquin HIV-1 subtype B standard has been quantified in copies/mL by different methods but the results obtained in the bDNA 3.0 assays were eventually used for value assignment. The liquid frozen VQC-Sanquin standard was calibrated against the 1st and 2nd International Standards in the WHO collaborative study. When we compared the bDNA 3.0 results the conversion factors (95%CI) were 0.39 (0.34-0.44) copies/IU when comparing the VQC-Sanquin standard against the 1st WHO HIV 97/656 standard, but 0.58 (0.51-0.66) copies/IU when calibrated against the 2nd WHO HIV 97/650 standard. These were data from the same WHO collaborative study showing that there has been a significant shift in the amount of HIV per IU when the 1st WHO standard was replaced by the 2nd WHO standard.
Currently the 4th WHO HIV 16/149 replacement standard is in use. It must be emphasised that the IU values assigned to the VQC Sanquin standard in the package insert are based on calibration to the 2nd WHO 97/650 standard. The later WHO standard and the VQC-Sanquin subtype B standard have been tested in hundreds of replicates to determine the 95% and 50% LODs of the Procleix Ultrio versions and more recently the cobas MPX assay.
Over the years HIV-1 standards of different subtypes and circulating recombinant forms (CRFs) have been used for validation of different NAT methods. In addition, HIV-2 and HIV group O standard dilutions were used in evaluation studies. More recently the number of HIV-1 subtypes, CRF and HIV group O plasmas has been expanded, but so far with fewer replicate NAT data.
The package insert of all the HIV subtype standard dilution panels gives an overview of the reactivity rates found with multiple replicate tests in different NAT methods. The response data in the package insert can be used as a reference when the panels are tested for determining the 95% and 50% LOD in validation studies. Currently the 10 member dilution panels are phased out and replaced by 8 member panels composed of 300, 100, 30, 10, 3, 1, 0.3 and 0.1 copies/mL samples.
HIV-RNA subtype reference panels
| Cat. No | HIV-RNA subtype reference panel | Source/Standard | Quantity | Range copies/mL | Range IU/mL | Storage Temp. | List Price |
|---|---|---|---|---|---|---|---|
| P0350 | HIV-1 RNA subtype B | 4th WHO 16/149 | 7 x 4 mL^ | 0.12 - 116 | 0.2 - 200 | ≤ -65˚C | €777,50- |
| P0290 | HIV-1 RNA subtype B | VQC-Sanquin § | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0291 | HIV-1 RNA subtype B inact. | VQC-Sanquin § inactivated | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0032 | HIV-1 RNA subtype A | BioQControl | 10 x 4mL^ | 0.2 - 5020 | 0.3 - 8655 | ≤ -65˚C | €777,50- |
| P0296 | HIV-1 RNA subtype A | BioQControl | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0027 | HIV-1 RNA subtype C | BioQControl | 10 x 4 mL^ | 0.1 - 2883 | 0.2 - 4971 | ≤ -65˚C | €777,50- |
| P0292 | HIV-1 RNA subtype C | BioQControl | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0033 | HIV-1 RNA subtype D | BioQControl | 10 x 4mL^ | 0.2 - 5610 | 0.3 - 9672 | ≤ -65˚C | €777,50- |
| P0297 | HIV-1 RNA subtype D | BioQControl | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0028 | HIV-1 RNA CRF01_AE (1) | BioQControl | 10 x 4 mL^ | 0.1 - 3075 | 0.2 - 5301 | ≤ -65˚C | €777,50- |
| P0293 | HIV-1 RNA CRF01_AE (1) | BioQControl | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0052 | HIV-1 RNA CRF01_AE (2) | Thailand | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0053 | HIV-1 RNA subtype F (1) | Brazil | 8 x 4 mL | 0.10 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0054 | HIV-1 RNA subtype F (2) | Romania | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0098 | HIV-1 RNA subtype G (1) | Zaire | 8 x 4 mL | 0.10 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0099 | HIV-1 RNA subtype G (2) | Kenya | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0051 | HIV-1 RNA CRF02_AG | Ghana | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0100 | HIV-1 RNA subtype H | Zaire | 8 x 4 mL | 0.1 - 300 | 0.2 - 517 | ≤ -65˚C | €777,50- |
| P0354 | HIV-2 RNA subtype A | 2nd WHO 16/296 | 8 x 4 mL^ | 0.24 - 237 | 0.3 - 300 | ≤ -65˚C | €777,50- |
| P0298 | HIV-2 RNA subtype A | BioQControl | 8 x 4 mL | 0.1 - 300 | 0.1 - 380 | ≤ -65˚C | €777,50- |
| P0212 | HIV-2 RNA subtype B | Belgium | 8 x 4 mL | 0.1 - 300 | 0.1 - 380 | ≤ -65˚C | €777,50- |
| P0015 | HIV RNA group O (1) | BioQControl | 10 x 4 mL^ | 0.1 - 2580 | 0.1 - 4448 | ≤ -65˚C | €777,50- |
| P0101 | HIV-RNA group O (2) | USA | 8 x 4 mL | 0.46 - 1382 | 0.79 - 2383 | ≤ -65˚C | €777,50- |
| P0102 | HIV-RNA group O (3) | Camaroon | 8 x 4 mL | 0.40 - 1197 | 0.69 - 2064 | ≤ -65˚C | €777,50- |
| P0103 | HIV-RNA group O (4) | Spain | 8 x 4 mL | 0.43 - 1281 | 0.74 - 2209 | ≤ -65˚C | €777,50- |
| P0104 | HIV-RNA group O (5) | Camaroon | 8 x 4 mL | 0.41 - 1233 | 0.71 - 2125 | ≤ -65˚C | €777,50- |
Kit Insert: KI4270
§ extensively calibrated on 1st and 2nd WHO standard
^10 x 4 mL format will be phased out and replaced by 8 x 4 mL format
#made for IVD manufacturer, alternative available on request
$regulatory status: all products are for research use only