SARS-CoV-2-Rapid Antigen test
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SARS-CoV-2 Antigen Test Kit (LFIA)

Certifications Product Information & Advantages Competitive Product Analysis Overall Protocol Requirements Packaging Summary & Contact T EST S F O R LIF E

Product Information & Advantages

The Importance of Antigen Tests • Infection rates are still increasing around the globe which inhibits the safe reopening society. • Unlike other SARS-CoV-2 testing methods, antigen tests are quick, inexpensive, and detect an active SARS-CoV-2 infection. • Frequent antigen rapid testing will significantly assist in identifying infectious individuals and quarantining

SARS-CoV-2 Antigen Test Kit (LFIA) • BioMedomics has continued to put their passion of fast and reliable COVID-19 testing methods into the new SARS-CoV-2 Antigen Test Kit (LFIA). • While PCR tests take days to reveal results and requires complex and expensive equipment, the SARS-CoV-2 Antigen Test Kit (LFIA) enables early detection of an acute coronavirus infection, enabling healthcare providers to administer faster and more accurate treatment methods. • Knowledge of active infection in the fastest time possible is epidemiologically important and is crucial in the spread and management of...

SARS-CoV-2 Antigen Test Kit (LFIA) Packing size: 20 tests/kit Specimen type: nasopharyngeal & throat secretion Instrumentation: not required Detection time: 15-20 minutes Storage: room temperature (2-30°C) Shelf Life: 24 months

SARS-CoV-2 Antigen Test Kit (LFIA) • A frequently administered low analytic sensitivity test (rapid antigen test) has a better chance of identifying a person during peak viral load – when risk of transmission is highest – than a high analytic sensitivity test (PCR) administered less frequently. • A PCR test can miss the earliest stages of infection and remain positive even after the patient is no longer infectious. Analytic Sensitivity Graph High frequency testing with low analytic sensitivity outperforms low-frequency testing with high analytic sensitivity.

SARS-CoV-2 Antigen Test Kit (LFIA) Technical Specifications • The SARS-CoV-2 Antigen Test is a lateral flow immunoassay (LFIA) that detects the most abundant protein (NP) antigen of SARS-CoV-2 using a double antibody sandwich assay. Schematic of the BioMedomics lateral flow immunoassay with SARS-CoV-2 monoclonal antibodies

Analytical Performance: Sensitivity (Limit of Detection- LOD) • In Limit of Detection (LoD) studies determined the lowest detectable concentration of SARSCoV-2 at which 100% of all (true positive) replicates test positive. • Because all concentrations tested positive, the SARS-CoV-2 Antigen Test demonstrates a high sensitivity. SARS-CoV-2 virus were diluted with lysis buffer to a final concentration gradient of 10, 50, 100, 200, 1000 TCID50/mL.

Clinical Sample Test Performance • Total 627 nasopharyngeal and throat swabs were collected from patients. Clinical Sample Performance • A PCR test was used as the comparator method to confirm the status of samples for this study. • BioMedomics’ s antigen test demonstrated a sensitivity of 97.73% and a specificity of 99.51% Two nasopharyngeal swabs were collected from patients and one swab was tested directly using BioMedomics SARS-CoV-2 Antigen Test Cassette.

Competitive Product Analysis

SARS-CoV-2 Antigen Test Kit (LFIA) Comparison with PCR Nucleic Acid Tests PCR Nucleic Acid Tests BioMedomics Antigen Test (LFIA) Turnaround Time Facility Requirement No special facilities needed Requires expensive equipment No electronic equipment needed Prone to false negatives Results are clear & easy to read Commonly used, gold standard Helps identify active infection Operation Clinical Value

Overall Protocol

SARS-CoV-2 Antigen Test Kit (LFIA) Sample Type Sample Type Storage Short term: 2-8°C for 8 hours Long term: store at -70°C Short term: 2-8°C for 8 hours Secretion Long term: store at -70°C

SARS-CoV-2 Antigen Test Kit (LFIA) Nasopharyngeal Secretion Collection 1. Take out a swab from the pouch. 2. Insert the swab into one of the patient’s nostrils until it reaches the posterior nasopharynx where there is the most secretion. 3. Gently rotate and rub the swab over the surface of the posterior nasopharynx for several times before taking it out.

SARS-CoV-2 Antigen Test Kit (LFIA) Throat Secretion Collection 1. Take out a swab from the pouch. 2. Insert the whole swab completely into the throat from the mouth, centering on the throat wall and the reddened area of the tonsil. 3. Wipe both sides of the pharyngeal tonsil and posterior pharyngeal wall with moderate force. Try to avoid the tongue before taking it out.

SARS-CoV-2 Antigen Test Kit (LFIA) Test Procedure 4. For nasopharyngeal swabs, vertically add 230 uL (about 10 drops) lysis buffer into the sampling tube; for throat swabs, vertically add 300 uL (about 13 drops) lysis buffer into the sampling tube. Insert the swab (after collection) into the solution. 5. Rotate the swab against the inner tube wall about 10 times. 6. Squeeze the swab from the outer tube wall to completely dissolve the sample in the solution. 7. Remove and discard the swab, cover the tube with the dropper. 8. Place 3 drops of buffer in sample well. Read results after 15...

SARS-CoV-2 Antigen Test Kit (LFIA) A total of two detection lines are possible, with the control (C) line appearing when sample has flowed through the cassette. 1| Invalid Result: If the quality control line (C) does not appear, then the test result is invalid and sample must be retested with a new cassette. 2| Negative Result: If only the quality control line (C) appears and the detection T line is not visible, the sample contains no novel coronavirus antigen or the antigen concentration is lower than the limit of detection and the result is negative. 3| Positive Result: If both the...

Internal Quality Control Procedure • Each Test Cassette device has a built-in control. • A red colored line in the detection window at the Control line can be considered an internal positive procedural control. • The Control line will appear if the test procedure has been correctly performed. • If the Control line does not appear, the test is invalid and a new test must be performed. • If the problem persists, please contact your local vendor or BioMedomics for technical support.