Rako Science today announced accreditation agency, IANZ, has amended the scope of the Rako Science PCR saliva test by removing the restriction "for surveillance purposes only". Testing can now be utilised for not just surveillance testing.
The IANZ accreditation is held by Rako Science’s contracted laboratory, IGENZ Ltd.
In January 2021, IGENZ Ltd, a contracted testing laboratory, achieved IANZ accreditation for saliva testing using the Rako Science methodology, based on validation work that used a set of contemporaneously collected paired saliva and nasopharyngeal samples.
“This means the Rako Science saliva test can be used by medical professionals on symptomatic patients on the COVID-19 frontline such as hospitals,” Rako Science Chief Science Officer Dr Stephen Grice said.
“New Zealand levels of testing are below what is required to get on top of the current Delta outbreak.
“Saliva testing for COVID is an extra tool for our medical professionals to encourage testing from those reluctant to have a nasal swab." Dr Grice said.
Rako Science’s current saliva collection systems employ non-medical professionals to oversee self-collection of samples from asymptomatic people for more than 20 companies in Auckland and across New Zealand.
“We won’t change our operational focus with this accreditation amendment, but it does mean we can now support health professionals with a tool that is diagnostically validated,” Dr Grice said.
Rako Science’s PCR saliva test is the only diagnostically validated test in New Zealand that meets the ISO15189 standard of identifying diagnostic sensitivity using paired samples. On 5 July 2021, the Ministry of Health agreed that Rako Science’s saliva test is at least as accurate as nasopharyngeal swab tests.
“The previous “gold standard” for COVID-19 testing was the nasal swab, but we have bought the best of international science to New Zealand to add this weapon to the arsenal," Dr Grice said.
“The Rako Science PCR saliva test’s accreditation, through its contracted laboratory, was based on a diagnostic validation study led by New Zealand’s most experienced pathology, molecular and microbiologists using 152 real world paired samples.
“The paired samples allowed us to determine the diagnostic sensitivity and the overall accuracy and we published that information and shared it with the Ministry of Health as soon as we had completed our diagnostic validation study.
“We would like to thank IANZ for their careful, but rapid decision,“ Dr Grice said.