SARS-COV-2 Cartridge-based PCR

EVALUATION OF CARTRIDGE-BASED KITS
Last updated: 14 April 2021

As the National Reference Laboratory for Emerging and Re-Emerging Infectious Diseases (NRL-EREID), the Research Institute for Tropical Medicine (RITM) is mandated to perform verification of infectious disease test kits. In April 2020, RITM announced that it can evaluate cartridge based test kits for SARS-CoV-2, as part of its response to the COVID-19 pandemic.

The evaluation procedures performed at RITM serve to: (1) verify manufacturer claims for assay performance, using the detection system/s available within its evaluation laboratories, (2) determine clinical or diagnostic sensitivity and specificity.

RITM results for assay performance evaluation may guide end-user laboratories in selecting assays to be employed within their respective laboratories, in addition to other considerations, such as the assay’s target genes, compatibility with existing laboratory equipment, approval of regulatory bodies, cost-effectiveness and other laboratory adoption requirements. End-user laboratories are still advised to perform their own verification, prior to assay adoption for diagnostic testing, as the testing conditions (instruments, other reagents, consumables, practices, etc) may vary from that of RITM’s at the time of evaluation.

Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.

METHODS

Performance evaluation involves comparison of the assay under evaluation and a reference assay.
The panel consists of nasopharyngeal and oropharyngeal swabs of known SARS-CoV-2 RT qPCR results, of sufficient volume for further testing and appropriately stored in -800C. A minimum of 30 positives and 30 negatives are typically included in each sample panel.

RITM technical evaluation standards for SARS-COV-2 PCR kits

STANDARDS

For PCR kits to be used in COVID-19 testing, the World Health Organization recommends a clinical sensitivity of >95% and specificity of >99%.
For PCR kits to be procured by the DOH, the HTAC recommends a clinical sensitivity and specificity of >99%. This standard metric is explained in depth in Rapid Review: SARS-COV-2 RT PCR Test Kits for the Diagnosis of COVID-19 Cases published by HTAC in May 2020.

The Health Technology Assessment Council (HTAC) is an independent advisory body with the overall role of providing guidance to the Department of Health (DOH) and the Philippine Health Insurance Corporation (PhilHealth) on the coverage of health interventions and technologies to be funded by the government.

RESULTS

#Kit NameManufacturerSensitivity (95% CI)Specificity (95% CI)Date Performed
1BioFire Respiratory Panel 2.1BioFire Diagnostics, LLC100% (88.43 to 100 CI)100% (88.43 to 100 CI)August 17-21, 2020
2i-densy Pack Universal SARS-CoV-2 Detection SystemArkray Industry Inc.100% (88.43 to 100 CI)100% (88.43 to 100 CI)October 5 to 9, 2020
3POCKIT CENTRAL SARS-CoV-2 (orf 1ab) Premix ReagentGeneReach Biotechnology Corp.68.42% (54.76 to 80.09 CI)100% (88.06 to 100 CI)October 23 to Novemeber 16, 2020
4EasyNat Diagnostic Kit for Novel-Corona Virus (2019-nCoV) RNA (Isothermal Amplification-Real
Time Fluorescence Assay)
USTAR Biotechnologies, Hangzhou Ltd.95% (86.08% to 98.96%)100% (88.06% to 100%)November 28 - December 11, 2020
5Cobas® SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the Cobas® Liat®
System
Roche Molecular Systems, Inc., Branchburg, NJ 08876, USA96.49% (87.89% t0 99.57%) 100% (87.66% to 100%)March 11 - 31, 2021

Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).

The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.