Store at temperature 2˚C to 30˚C The instructions for use cover the following product codes: ID-COV19-01, ID-COV19-02, ID-COV19-03 and ID-COV19-04 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. Each kit contains reagents and materials for use on the Genedrive® instrument only. Use on third party equipment is not supported. Terms & Abbreviations Table of contents Internal Process Control Open Reading Frame Ribonucleic acid Personal Protective Equipment SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Materials required but not supplied Specimen collection, handling and storage Storage and shelf life Operating conditions Test procedure Expected Results Quality Controls Viral Transport Media World Health Organization Performance characteristics 14 Quick reference guide 20 Manufacturers details

Intended use The Genedrive® COV19-ID Kit is an automated, real-time molecular test for the qualitative detection of RNA from the SARS-CoV-2 virus in nasal mid-turbinate swabs from symptomatic or asymptomatic individuals to aid in diagnosis of COVID-19. The Genedrive COV19-ID Kit is for use with the Genedrive instrument (GD-003). Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection, or co-infection with...

Kit components Product Number Genedrive® COV19-ID Kit (box of 25 tests including 2 controls) Genedrive COV19-ID Kit (box of 5 tests including 2 controls) Each ID-COV19-01, ID-COV19-02 or ID-COV19-04 Kit box contains the following components: Genedrive assay cartridge Genedrive assay cartridge lid Collection swab Transfer capillary Lyophilised amplification reagents in polycarbonate cartridge. Non-hazardous Polycarbonate Assay Cartridge lid. Non-hazardous Plastic. Non-hazardous Specimen collection tube containing buffer Negative control - Desiccant pouch 1.5mL flat bottom polypropylene tube with...

Materials required but not supplied Equipment Genedrive instrument (GD-003) Powder-free disposable gloves PPE required for swab collection as defined by local requirements Specimen collection, handling and storage The Genedrive® COV19-ID Kit is intended to be used on nasal mid-turbinate swabs collected from individuals over the age of 2 years. The collection swab should ONLY be used for nasal midturbinate sample types. DO NOT use other sample types with this test e.g. saliva or nasopharyngeal/oropharyngeal. If excessive levels of blood are seen on the collection swab, discard and collect a fresh...

Immediately discard any assay cartridges where the lyophilised reagents are absent (reagents should be present in channels 1 and 2 only). The test should be performed in a clean environment on a flat surface, free from sources of vibration or mechanical shock. Only use the specimen buffer provided with the Genedrive® COV19-ID Kit. DO NOT place collection swabs in viral transport media (VTM) after specimen collection. Do not use the specimens collected in Genedrive COV19-ID Kit specimen buffer with any third party tests. Do not use specimens collected with third party specimen collection liquids....

Test procedure Failure to follow the IFU could cause inaccurate test results. Wear clean powder-free disposable gloves throughout the procedure. To test an individual specimen follow sections 1 and 3 below. To test a Control follow sections 2 and 3 below. 1. Specimen collection 1.1 Using the labels provided, label the specimen collection tube. Ensure the label is attached to the top part of the specimen collection tube, so the liquid is still clearly visible. 1.2 Ensure the individual blows their nose into a tissue and discards. 1.3 When ready to collect the specimen from the individual, peel...

3.3 Before removing the strip cap from the assay cartridge, ensure that the lyophilised reagents are located at the base of channels 1 and 2 only (channel 3 of the assay cartridge is empty). (See Figure 3). If reagents are absent from either channels 1 or 2 discard the assay cartridge and return to step 3.2. 3.4 Label the assay cartridge lid with the specimen identification details. Open the assay cartridge lid and place both along with the specimen collection tube on a flat surface. 3.7 Remove the screw cap top from the specimen collection tube. Hold the specimen collection tube at a 45° angle,...

instrument until a ‘click’ is heard, which is indicative of complete cartridge insertion. the assay cartridge lid before disposal. 3.20 If not required for re-test, discard the specimen collection tube in the routine clinical waste according to local procedures. 3.16 Start the test on the Genedrive® instrument by holding down the function button for 3 seconds. 3.17 The Genedrive® instrument will continually monitor the test for the presence of a positive signal. A ‘beep’ will notify the user when the test is completed. Positive results will be available in as little as 7.5 minutes and negative...

Quality controls The Genedrive® instrument is provided factory calibrated and does not require user calibration. The following conditions will indicate a retest: Internal controls The Genedrive COV19-ID Kit contains an internal process control (IPC) designed to control for specimen inhibition and reagent function. Presence of assay inhibitors in the specimen may result in false negative results. If neither SARS-CoV-2 or IPC is detected, a ‘Test Fail’ result is returned. In positive specimens, the IPC is ignored and the target amplification for SARS-CoV-2 is used to dominate result interpretation....

Analytical specificity (Cross reactivity) The Genedrive® COV19-ID Kit is exclusive for non-CoV-2 human pathogens listed in Table 2 below. Analytical specificity was assessed against relevant human respiratory system organisms as listed by the World Health Organization (WHO) document PQDx_347 version 2. Exclusivity was determined in silico for all (<80% match of primers and probe, with none resulting in viable amplification products), and where available experimentally at the copies per reaction shown in the table. Table 2. Exclusivity Data for Genedrive® COV19-ID Kit In silico Experimental Exclusivity...