Post-market review of HIV nucleic acid tests

The TGA is undertaking a post market review of NATs intended to screen, diagnose, and monitor HIV, to investigate concerns raised regarding the risk of false positive results in individuals undertaking chimeric antigen receptor (CAR) T-cell therapy.

Updates on the post market review will be published on this page as further information becomes available.

Background of the review

The TGA has received signals about false positive HIV NAT results in individuals that have undergone CAR T-cell therapy.

CAR T-cell therapy is a new advanced treatment that uses a person’s own immune cells (T- cells) and alters them to target certain blood cancers that do not respond to more traditional forms of treatment. Several CAR T-cell therapeutics are approved for use and included in the Australian Register of Therapeutic Goods (ARTG).

As part of a patient’s management plan, they may be tested for various infectious diseases including HIV. Due to the cross-reactivity between some HIV NAT assays and CAR T-cell therapies, there is a risk of a patient receiving a false positive HIV result. A test for HIV antigens or antibodies can be used to identify false positives, as these are not affected by the cross-reactivity. It is important to note that it is not the CAR T-cell therapy that carries the risk of HIV infection.

Due to the cross-reactivity between some NAT assays and CAR T-cell therapies, there is a risk of a patient receiving a false positive HIV result, particularly if this risk is not clearly identified in the Instructions for Use (IFU), to inform the laboratory-trained personnel.

The purpose of the review is to identify if any of the HIV NATs included in the ARTG are at risk of false positive results due to reactivity with CAR-T therapy and work with manufacturers of affected NATs, to update their IFU to identify the risk of cross-reactivity, if applicable.

Information for consumers and healthcare professionals

Consumers that are currently or have previously undertaken CAR T-cell therapy should consult their treating health practitioner if they have any concerns regarding the safety or performance of HIV test devices or test results and discuss alternative testing options such as antigen/antibody tests or repeating tests on another NAT platform.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.