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RV008 WHO EUL Listed!
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We, KH Medical is honored to be the unique COVID-19 PCR KIT which has 100% of Sensitivity & 100% of Specificity on FIND Evaluation.
FIND (Foundation for Innovative New Diagnostics) is WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. FIND is working in partnership with WHO to accelerate development and access to diagnostics as part of the global response to the COVID-19 pandemic.
This diagnostics resource centre is designed to support policymakers and healthcare providers with up-to-date information on tests and testing for SARS-CoV-2 (the causative agent of COVID-19). FIND is conducting independent evaluations of SARS-CoV-2 molecular tests. Data from these evaluations is current available checking on FIND’s web page.(https://www.finddx.org/covid-19/sarscov2-eval-molecular/molecular-eval-results/)
All data is made openly accessible on their website and shared with WHO, in order to help inform procurement and implementation decisions for countries and health programs – specifically those with limited capacity to conduct their own independent evaluations.
* Objective(s)
Verify the analytical sensitivity, i.e. lower limit of detection, of commercially available COVID-19 NAT diagnostic kits using contrived specimens containing known, limited quantities of whole virus.
Determine the diagnostic performance (sensitivity and specificity) of commercially available COVID-19 NAT diagnostic kits in previously characterized clinical respiratory samples (SARS-CoV-2 positive and negative).
* Sample size :
- 50 COVID-19 reference RT-PCR positive samples
- 100 COVID-19 reference RT-PCR negative samples
* Comparator Assay : In-house assay optimized from TIB MOLBIOL assay
* PCR Platform : Biorad CFX96 deep well
* Results :
- Limit of Detection: 1-10 copies/Rxn for S Gene, 10-50 copies/Rxn for RdRP Gene
- Sensitivity: 100%
- Specificity: 100%