EVALUATION OF CARTRIDGE-BASED KITS
Last updated: 28 December 2020
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.
Performance evaluation involves comparison of the assay under evaluation and a reference assay.
The panel are comprised 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.
Extraction of RNA material from sample panels are carried out using either commercially available: 1) spin column-based extraction kits or 2) magnetic bead-based extraction kits.
The RNA extracts were tested by real-time reverse transcriptase polymerase chain reaction (qRT-PCR) using either using commercially available test kits or laboratory-developed tests for SARS-CoV-2 detection by PCR.
|#||Kit Name||Manufacturer||Lot Number||Sensitivity||Specificity||Analytical Specificity||Analytical Sensitivity||Date Performed|
|1||BioFire Respiratory Panel 2.1||BioFire Diagnostics, LLC||1309520||100% (88.43 to 100 CI)||100% (88.43 to 100 CI)||100%||August 17-21, 2020|
|2||i-densy Pack Universal SARS-CoV-2 Detection System||Arkray Industry Inc.||D070E96||100% (88.43 to 100 CI)||100% (88.43 to 100 CI)||100%||October 5 to 9, 2020|
|3||POCKIT CENTRAL SARS-CoV-2 (orf 1ab) Premix Reagent||GeneReach Biotechnology Corp.||Extraction Cartridge: 0707204|
Reagent Premix: SCoV2orf1abC0714207
|68.42% (54.76 to 80.09 CI)||100% (88.06 to 100 CI)||40 copies/ul||October 23 to Novemeber 16, 2020|
|4||EasyNat Diagnostic Kit for Novel-Corona Virus (2019-nCoV) RNA (Isothermal Amplification-Real|
Time Fluorescence Assay)
|USTAR Biotechnologies, Hangzhou Ltd.||200901||95% (86.08% to 98.96%)||100% (88.06% to 100%)||between 0.5 copies/μl to 0.8 copies/μl.||November 28 - December 11, 2020|
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.