High HbA1c Test Results with New Roche Method
On 31 March 2025, Awanui Labs introduced a new method for HbA1c testing used in the diagnosis and monitoring of diabetes. This change involved transitioning from the Bio-Rad D-100 to the Roche C513 analyser, following completion of comparator studies.
While the Roche method is known to produce slightly higher HbA1c results than the Bio-Rad method, this variation is within the acceptable range set by the Royal College of Pathologists of Australasia (RCPA). However, following implementation, we received multiple reports from GPs indicating a trend of unexpectedly high HbA1c results in monitored patients, suggesting a greater-than-anticipated positive bias between the two methods.
We have since investigated the issue thoroughly, engaging both the test manufacturer (Roche) and other laboratories. The source of the bias has been identified, and we have taken corrective action. As of 12 July 2025, a change has been implemented to address this issue. We apologise for any impact this may have had on patient diagnosis, monitoring, or treatment, and appreciate those who have brought this to our attention.
Recommended action: We advise reviewing any unexpectedly elevated HbA1c results reported between 31 March and 11 July 2025. Where appropriate, please consider retesting.
Thank you for your understanding and support. If you have any questions or need further information, please don’t hesitate to contact us.
Warm regards,
Dr Melissa Yssel – Clinical Lead, Chemical Pathology, Awanui Labs
Dr Owen Wiese – Chemical Pathologist, Awanui Labs
Seminal Fluid Collection for Fertility
Please advise patients that samples are required to be delivered to Awanui Labs Bell Block site at 1 Paraite Road, New Plymouth within 1 hour of collection. A patient information guide can be found on the Awanui Labs Taranaki website.