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Patient Report Updated 7/31/21 Accel Diagnostics © 2021 CLIA Certified High Complexity Laboratory ADX Diagnostic Lab, A Part of Accel Diagnostics CLIA ID Number: 45D2192790 5930 Star Lane Suite D, Houston, TX 77057 CLIA Director: Sanam Koirala, DCLS, MS, CC (NRCC), MLS (ASCP) W: www.acceldx.com/adxlab E: [email protected] Ph: 713-242-8658 | Fax: 713-242-8658 Patient’s Name: Click here to enter text. Date of Birth: Click here to enter a date. Gender: ☐ Male ☐ Female Specimen collection date: Click here to enter a date. Specimen Type: Plasma Accession Number: _________________________ Additional Info: _____________________________ Test Name and Type: RapidQ S-IgG Antibody Cards™ | COVID-19 Semi-Quantitative Antibody Test. Result Anti-Spike Antibody Reference Range Concentration (AU/mL) Negative/Non-Reactive Reference Range: < 4 AU/mL Test Description: This test is intended as an aid to identify individuals with an adaptive immune response to SARS-CoV-2 (COVID-19), indicating recent or prior infection. This test is a rapid immunoassay for the semi-qualitative detection of the IgG antibodies against the Spike protein (S-protein) of SARS-CoV-2, the virus that causes COVID-19 disease. Individuals who have been vaccinated with a SARS-CoV-2 spike or receptor-binding domain vaccine (e.g., Moderna, and Pfizer) may be positive with this test. The result of test is reported in Arbitrary Units per milliliter (AU/mL). Warning: The result of this test should not be interpreted as an indication of degree of immunity or protection from reinfection. The clinical significance of a positive antibody result for individuals who have received a COVID-19 vaccine is unknown. It is yet not known how the concentration of antibody against the SARS-CoV-2 spike protein correlates to immunity to COVID-19. It is not known how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This assay should not be used to diagnose acute SARS-CoV-2 infection. Studies in our and other laboratories are underway to measure the quantitative levels of specific SARS-CoV-2 antibodies following vaccination. Such studies are expected to provide important insights into the correlation between protection from vaccination and antibody levels. Test Result Interpretation: • Negative (Non-reactive): A test result that is less than 4 AU/mL is negative. A negative test result means that antibodies were not detected in the blood sample by the test. Negative results do not preclude acute SARS-CoV-2 infection. Negative results may occur in samples collected too soon following infection (i.e., if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay), if the virus has undergone amino acid mutation(s) in the epitope recognized by the antibody used in the test, or in immunosuppressed patients. A negative result mean that the individual has not been previously infected with SARS- CoV-2. The clinical significance of a negative antibody result for individuals that have received a COVID-19 vaccine is unknown. The performance of the test has not been established in COVID-19 vaccinees. False negative results for the ADX Diagnostic Lab is a CLIA High Complexity Laboratory | CLIA Number: 45D2192790 Page. 1/2 This document contains private and confidential health information protected by state and federal law. If you have received this document in error, please call 713-242-8658. Accel Diagnostics © 2021 - All Rights Reserved. test may occur if the individual's antibodies have not reached a sufficient level for the test to be able to detect them. Antibodies can take up to two to three weeks (sometimes longer) to develop after someone is infected. How long antibodies to SARS-CoV-2 last after infection is not known. Follow-up testing with a molecular SARS-CoV-2 test is recommended in symptomatic persons. This test should not be used to eXclude acute/recent coronavirus disease 2019 (COVID-19). • Positive (Reactive): A test result that is 4 AU/mL or greater is positive. A positive result means that antibodies against the SARS-CoV-2 Spike protein have been detected. A positive result could mean an immune response to a recent or prior infection with SARS-CoV-2. Positive results may occur after COVID-19 vaccination, but the clinical significance of a positive antibody result for individuals that have received a COVID-19 vaccine is unknown, and the performance of the test has not been established in COVID-19 vaccinees. False positive results for the test may occur due to cross- reactivity from pre-existing antibodies or other possible causes. It is currently unknown how long antibodies to SARS-CoV-2 remain present in the body after infection and if they confer immunity to infection • Antibody Concentration: Antibody concentration varies greatly between individuals. A study conducted in our laboratory, in subjects that received both doses of the Moderna vaccine, found that the concentration of anti-spike antibody increases sharply after the second vaccine dose, and starts to decrease shortly after. The average antibody concentration in our study was found to vary as shown below. These data are only indicative and do not imply any level of immunity. Range 1 = 1 and 14 days after the first dose Range 2 = 15 and 30 days after the first dose Range 3 = 31 and 60 days after the first dose 211 Range 4 = 61 and 90 days after the first dose Range 5 = 91 and 150 days after the first dose 123 Spike Antibody Antibody Spike - 45 47 Anti 1 Concentration (AU/mL) Concentration Range 1 Range 2 Range 3 Range 4 Range 5 Further Consideration: • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS- CoV-2 is necessary. • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Testing Completed: Click here to enter text. Report Date: Click here to enter a date. Disclaimers: This test is a Laboratory Developed Test (LDT). This test was developed, and its performance characteristics determined by ADX Diagnostic Lab in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This test is not intended to be used as a diagnostic test for COVID-19 infection or to indicate the degree of immunity or protection from reinfection. ADX Diagnostic Lab is a CLIA High Complexity Laboratory | CLIA Number: 45D2192790 Page. 2/2 This document contains private and confidential health information protected by state and federal law. If you have received this document in error, please call 713-242-8658. Accel Diagnostics © 2021 - All Rights Reserved. .
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