Laboratory update: Bio-Rad kit supply issues

On 19^th July 2024 Health Services Laboratories (HSL) were informed by the supplier (Bio-Rad) of the Geenius assay that there are also supply issues with this assay as well. There is no clear indication from the supplier when these issues with the HIV confirmation assays will be resolved.

Therefore, to conserve stock of the Geenius assay it is necessary to temporarily change the HIV confirmation pathway.

This change will come into effect from Wednesday 24^th July 2024.

• All samples which are reactive on the Roche HIV Ab/Ag assay but non-reactive in the Abbott HIV Ab/Ag assay will not have a Bio-Rad Geenius assay performed. These samples will be reported as Indeterminate by the laboratory and either a HIV-1 viral load or HIV-1 qualitative HIV-1 RNA will be added dependent on sample type.
• All samples which are reactive in both the Roche HIV Ab/Ag assay and the Abbott HIV Ab/Ag assay will have a Bio-Rad Geenius assay performed unless the sample is from a known HIV positive patient.

Dr Gee Yen Shin, HSL Virology clinical lead, has informed the Virology clinical lead for each trust of these changes to the HIV confirmation pathway on 19^th July 2024.

Contact:

If any further information is required relating to this temporary change, please contact Wendy Chatterton wendy.chatterton@hslpathology.com