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The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

The FINDER Flu A&B/SARS-CoV-2 Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu A&B/SARS-CoV-2 Test may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test intended for the qualitative detection of viral RNA from influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), from nasopharyngeal samples.

FINDER Flu A&B/SARS-CoV-2 Test is performed using a single-use test cartridge that contains all the reagents necessary to perform the test. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps required to perform the multiplexed, real-time RT-PCR test. The time to result is approximately 20 minutes from sample introduction.

The FINDER Flu A&B/SARS-CoV-2 Test is run on the FINDER Instrument. The instrument is supplied with all the hardware and software required for the electrowetting control, thermal control, and multicolor fluorescence detection capabilities that are required to perform the test. The instrument also features a touch-screen user interface and the software application that performs the test and reports the results.

The FINDER Flu A&B/SARS-CoV-2 Test commences with the collection of a nasopharyngeal swab in a sample collection media (FINDER RVP Buffer) provided by Baebies. To perform a test, the operator inserts the test cartridge into the instrument, follows the onscreen instructions to setup a test and then loads a 200µL sample using the provided exact-volume transfer pipette.

The instrument automatically performs all sample preparation steps once the sample is introduced on the test cartridge. The sample is lysed in a chaotropic (guanidine) lysis reagent in the FINDER RVP Buffer and is further lysed using proteinase K on the cartridge. Paramagnetic beads and a binding buffer (with ethyl alcohol) are added to the lysed sample to precipitate the nucleic acid onto the beads. The beads are then washed and eluted in a buffer.

The eluate is split into two droplets. One droplet is mixed with reagents to amplify and detect SARS-CoV-2. The second droplet is mixed with reagents to amplify and detect influenza A and influenza B. An internal control (RPP30) is also amplified and detected in each droplet to verify that the test system is working as expected and that sufficient specimen was added.

Reverse transcription (RT) is performed on both droplets. This is followed by Polymerase Chain Reaction (PCR) by shuttling the droplets between an annealing zone and denaturing zone on the cartridge. Reactions are performed in parallel on both droplets under the two multicolor detectors. The fluorescence is measured at each cycle and the cycle threshold (Ct) is automatically calculated for each target using software algorithms. Within droplets, multiple target reactions produce fluorescence at different wavelengths, allowing analysis of multiple viral targets in parallel.

After the test is complete, the software computes test results which are then displayed to the user and optionally printed.

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