SARS-CoV-2 Test 60061-7 (2021-01) Accula SARS-CoV-2 IFU 1
SARS-CoV-2 COV4100 For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use For use with Nasal and Nasal Mid-Turbinate Swabs For use with the Accula™ Dock and Silaris™ Dock Instructions for Use INTENDED USE The Accula™ SARS-CoV-2 Test performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-col
process positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. There are 4 steps in the process: 1. Lysis of the virus 2. Reverse transcription (RT) of viral RNA to cDNA 3. Nucleic acid amplification by thermocycling polymerase chain reaction (PCR) 4. Detection The Accula Dock controls reaction temperatures, timing, and fluid movements within the Test Cassette resulting in a fast and automated SARS-CoV-2 RT-PCR assay.
MATERIALS PROVIDED SEPARATELY • Accula Dock (Catalog # D2000) or Silaris Dock (Catalog #1026) • Accula SARS-CoV-2 Control Kit (Catalog #COV4100-1) STORAGE AND HANDLING • Store reagents at room temperature (15°C to 30°C, 59°F to 86°F). Do not refrigerate or freeze. • Do not reuse kit contents: Collection Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, or SARS-CoV-2 Buffer. • Do not remove the Test Cassette from the foil pouch until immediately before use (within 30 minutes).
• • • • • When transferring the eluted patient sample, avoid drawing up large particulates, which may clog the Transfer Pipette. Due to the high sensitivity of the Accula SARS-CoV-2 Test, contamination of the work area with previous samples may cause false positive results. Clean the Accula Dock or Silaris Dock and surrounding surfaces as described in the procedure in the Accula Dock or Silaris Dock Operators Guide. Do not attempt to open a used Test Cassette or a Test Cassette with closed sample port.
SPECIMEN COLLECTION Each test should be completed with a nasal swab sample using one SARS-CoV-2 Buffer vial. Proper sample collection is an important step for an accurate test result. Carefully follow the instructions below. NOTE: Use only the Collection Swabs supplied with the kit or one of the approved swab types listed below: Nasal Swabs: • Puritan Sterile Rayon Swab w/ Polystyrene Handle (REF. 25-806-1PR) • Puritan Sterile Standard Foam Swab w/Polystyrene Handle (REF.
Write the patient identification (ID) information and testing date onto the SARS-CoV-2 Buffer vial label in the area provided. Insert the nasal swab specimen into the SARS-CoV-2 Buffer and rotate it 5 times rubbing it against the wall of the vial. Remove the patient nasal swab from the SARS-CoV-2 Buffer vial and discard it into a biohazardous waste container. NOTE: If the buffer solution contacts the skin, wash the area with soap and clean water and rinse thoroughly.
Open the Dock by depressing the black button located on the top left. Verify the Dock screen displays: “DOCK READY INSERT CASSETTE”. Do not open the foil pouch until the sample is ready for testing. Initiate the test within 30 minutes of opening. Remove a Test Cassette and Transfer Pipette from the foil package (these items are packaged together). Write the patient identification (ID) information and testing date on the Test Cassette label in the area provided.
Invert SARS-CoV-2 Buffer vial to mix. Remove the cap from the eluted patient sample in the SARS-CoV-2 Buffer. Firmly squeeze the TOP bulb of the pipette. Squeeze While continuing to squeeze the top bulb firmly, place the pipette tip well below the surface of the liquid in the SARS-CoV-2 Buffer vial. Keep the pipette tip well below the surface of the liquid of the vial containing the eluted patient sample in SARS-CoV-2 Buffer vial.
Dispose of the pipette in a biohazardous waste container. The Dock screen will then read: “SAMPLE LOADED CLOSE LID”. Close the lid of the Dock immediately to automatically begin the test program. Verify the Dock screen displays: “SAMPLE LOADED LID CLOSED”. Verify the Dock screen displays: “CASSETTE SEALED TEST STARTED”. Verify the Dock screen displays: “TEST RUNNING REMAINING XX:XX”. Note: The test takes approximately 30 minutes to complete.
Open the lid of the Dock. Remove the Test Cassette and interpret the results according to the Interpretation of Results section below. Note: Results should be interpreted within 1 hour of test completion. SARS Co 2 Dispose of the Test Cassette in the biohazardous waste container.
INTERPRETATION OF RESULT NOTE: LOOK CLOSELY WHEN INTERPRETING RESULTS! The appearance of any shade of Blue Test Line at the “T” position is a valid result that is interpreted as positive for SARS-CoV-2. A negative result will only contain a Blue Test Line at the “C” position.
DOCK CLEANING Mesa Biotech recommends cleaning the Dock each day it is used. Procedure: Clean the Accula or Silaris Dock and surrounding area according to the instructions provided in the cleaning section of the Accula Dock or Silaris Dock Operator's Guide. LIMITATIONS • The performance of the Accula SARS-CoV-2 Test was determined using the procedures provided in this Instructions For Use. Failure to follow these procedures may alter test performance.
E. Authorized laboratories must collect information on the performance of the test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Mesa Biotech, Inc. Technical Support (via email: info@mesabiotech.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the test of which they have become aware. F.
N gene Reverse Primer Detection Probe Capture Probe testing with sequences carrying this mutation show showed a potential for reduced sensitivity. Please see Table 2. 34768 of 35556 complete SARS-CoV-2 genome sequences share 100% homology to the Reverse Primer. 35470 of 35556 complete SARS-CoV-2 genome sequences share 100% homology with the 3’ terminal 6 bases of the Reverse Primer. 35435 of 35556 complete SARS-CoV-2 genome sequences share 100% homology to the Detection Probe.
Legionella pneumonphila Mycobacterium tuberculosis Streptococcus pneumoniae Streptococcus pyogenes Bordetella pertussis Mycoplasma pneumoniae Pneumocystis jirovecii Candida albicans Pseudomonas aeruginosa Staphylococcus epidermis Staphylococcus salivarius No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found No alignment found Exclusivity (Cross-Reactivity) Testing The ex
Cross-Reactivity Testing for the Accula SARS-CoV-2 Test Target Organisms Organism Reference Number or strain available Unit Concentration Tested % Agreement with Expected Result Adenovirus (e.g. C1 Ad. 71) Type 1 TCID50/mL 5.10E+06 100% (3/3) Human Metapneumovirus (hMPV) IA14-2003 TCID50/mL 1.00E+05 100% (3/3) Parainfluenza Type 1 Type1 TCID50/mL 1.00E+05 100% (3/3) Parainfluenza Type 2 Type2 TCID50/mL 1.00E+05 100% (3/3) Parainfluenza Type 3 Type3 TCID50/mL 1.
Analytical Specificity - Interfering Substances To assess substances with the potential to interfere with the performance of the Accula SARS-CoV-2 Test, contrived samples with SARSCoV-2 RNA (SARS-CoV-2 RNA/strain USA_WA1/2020) were tested in replicates of three (3) with each interfering substance at the “worst case” concentration, and negative samples without RNA were tested in replicates of two (2) with each interfering substance at the “worst case” concentration.
Potential Interferent Mucin, Type II (from porcine stomach)2 Tobramycin (antibacterial)3 Active Ingredient Purified mucin protein Final Concentration Target % Agreement with Expected Results 50 mg/mL Positive SARS-COV-2(3X LoD) 100% (3/3) 100 mg/mL Negative 100% (2/2) Positive SARS-COV-2(3X LoD) Negative Positive SARS-COV-2(3X LoD) Negative Positive SARS-COV-2(3X LoD) Negative Positive SARS-COV-2(3X LoD) Negative Positive SARS-COV-2(3X LoD) Negative Positive SARS-COV-2(3X LoD) Negative Positive S
together in a vial of Accula SARS-CoV-2 Buffer. Positive samples were prepared from these thirty negative samples. Positive samples were spiked with SARS-CoV-2 RNA (SARS-CoV-2 RNA/strain USA_WA1/2020) at the concentrations shown in the table below. Samples were randomized, de-identified and blinded to the testing operator. Sample concentration and test results are summarized in the table below. 100% agreement was observed with expected results.
Testing of Clinical Samples Retrospective Specimen Study Fifty (50) retrospective clinical specimens, which had already been tested with a EUA authorized SARS-CoV-2 Real-Time RT-PCR Assay were tested with the Accula SARS-CoV-2 Test. Each specimen was diluted in the minimum amount of Accula SARS-CoV-2 Buffer required to obtain a valid Accula test result (presence of a control line), as VTM can inhibit the assay. Required dilutions ranged from 1:6 to 1:40. Test results are summarized in the table below.
SYMBOLS This symbol indicates that the product is for single-use only. It is not to be re-used This symbol indicates that you should consult the instructions for use. This symbol is used for both warnings and cautions. A warning indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed. A caution indicates the possibility of loss of data or damage to, or destruction of, equipment if operating procedures and practices are not strictly observed.
Mesa Biotech, Inc. 6190 Cornerstone Court East Suite 220 San Diego, CA 92121 USA 858-800-4929 info@mesabiotech.
