Genedrive® 96 SARS-CoV-2 Kit ID-CoV2-01-LPC (Low Profile Version) ID-CoV2-01-FPC (Fast Plate Version) ID-CoV2-01-BPC (Bio Plate Version) For the most up to date version of this document, please visit www.genedrive.com IMPORTANT: Please read these instructions prior to using this kit. Terms & Abbreviations cDNA Conformite Europenee-in vitro diagnostic Deoxyribonucleic acid Compatible RNA extraction methodologies Deoxyribonucleotide triphosphates Materials required but not supplied Specimen collection, handling and storage Polymerase Chain Reaction Storage and shelf life Real-Time PCR Real-Time Polymerase Chain Reaction Operating conditions Ribonucleic acid Reverse Transcription Polymerase Chain Reaction Test procedure Severe acute respiratory syndrome coronavirus 2 Result interpretation World Health Organization Genedrive® 96 Exporter – result interpretation Quality controls Performance characteristics Quick reference guide – manual set up Manufacturer details

Intended use The Genedrive® 96 SARS-CoV-2 Kit is intended to be used for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the...

Principles of the procedure Genedrive 96 SARS-CoV-2 Kit is a simplified one-step test designed for the diagnosis of SARS-CoV-2 from RNA extracts derived from upper respiratory swabs. All the reagents required for the test are supplied as a lyophilised bead, to which the specimen is added prior to running the test. The genetic targets are species-specific sequences which are located in the E and N genes of the virus. The target is amplified via a one-step RT-PCR reaction, whereby RNA conversion to cDNA and subsequent asymmetric amplification of cDNA occurs within the same well without the need...

For all RNA extraction methodologies, ensure optional or additional steps suggested in the extraction kit instructions for use are taken to reduce ethanol or wash buffer carryover as much as possible to reduce the chance of reaction inhibition, which could impact test sensitivity. Compatible Real-Time PCR instrumentation The Genedrive 96 SARS-CoV-2 Kit is available as low profile Bio or fast 96-well plates and is validated for use with the following Real-Time PCR instrument. Product name Product code Roche Diagnostics Thermo Fisher Scientific Other instruments may be compatible, however an end...

Kit components Catalogue number Genedrive 96 SARS-CoV-2 Kit – Low Profile Plate CE-IVD (96 reactions per kit) Genedrive 96 SARS-CoV-2 Kit - Fast Plate CE-IVD (96 reactions per kit) Genedrive 96 SARS-CoV-2 Kit - Bio Plate CE-IVD (96 reactions per kit) 96 well low profile, Bio or fast bar-coded plate containing lyophilised reagent mix in each well. Each plate is supplied foil-sealed Optical film seal Desiccant pouch Ordering details: Ensure the correct plate type is used for the instrument Catalogue number: ID-CoV2-01-LPC Company LightCycler 480 II Real-Time PCR System Catalogue number: ID-CoV2-01-BPC...

Specimen collection, handling and storage The Genedrive 96 SARS-CoV-2 Kit is intended for use on RNA extracts stored in viral transport media and derived from upper respiratory specimens. Warnings and precautions • RNA is extremely susceptible to shearing by freezethaw cycles. Ensure freeze and thaw of all fresh specimens and extracted RNA from specimens is kept to an absolute minimum to prevent failed tests Due to the sensitivity of RNA toward shearing by freeze thaw, do not use specimens that have undergone more than one freeze-thaw cycle either pre- or post-extraction. • RNA samples are susceptible...

Limitations of use The Genedrive 96 SARS-CoV-2 Kit has been validated for use with upper respiratory specimens run on the Roche LightCycler 480 II, Applied Biosystems 7500 Fast Real-Time PCR systems and Bio-Rad CFX96. False positive results may be caused by: Any deviations from the procedures detailed within this IFU may result in erroneous results or failure. • Local contamination caused by unsuitable handling of PCR amplicons Samples should be handled and treated as if they are infectious and all biosafety precautions should be followed. False negative results may be caused by: All results...

Test procedure 1. RNA Extraction The Genedrive 96 SARS-CoV-2 Kit is intended for use with commercially available RNA extraction kits and Human Lymphocyte RNA (AMSBIO, ATR1254148-10) and is validated for use with the RNA extraction kits listed in Table 3. Use of the Extraction Control - Human Lymphocyte RNA Human Lymphocyte RNA may be used as an optional extraction control to assess RNA extraction performance. When included in the RNA extraction procedure, successful RNA extraction and test performance will be indicated by positive detection of RNase P. The Extraction Control is supplied in an...

Table 3 RNA extraction kits and extraction control requirements Extraction Process Control Product code Lysis buffer volume/ specimen (µL) (A) Quantity of extraction control required per extraction (ng) (B) Quantity of extraction control required per 20 µL assay (ng) RNAdvance Viral RNA Purification Kit Beckman Coulter QIAamp Viral RNA Mini Kit Virus/Pathogen Kit with QIAamp MiniElute Virus Spin Kit RNAdvance Viral RNA purification kit (Beckman Coulter): Reagent volume produced will allow for at least 96 extractions (with 15% overage) 1. Remove a single use aliquot (30 μL of 5 ng/μL) of the RNA...

The procedure must be conducted in accordance with the manufacturer’s instructions for use. Ensure that specimen swabs have been handled according to the conditions set out in the Specimen collection, handling and storage section of this IFU. If using an automated extraction system, perform the extraction using specimen input to eluate volume ratio of 5:1 - for example, use a 200 μL specimen input volume with a 40 μL elution volume. Alternative nucleic acid extraction systems and kits might also be appropriate. If using a spin column based sample preparation procedure including washing buffers...