For in vitro diagnostic use. Others Elecsys Anti-SARS-CoV-2 S IVD Elecsys® Anti-SARS-CoV-2 S CPS_000616 09289275190 Anti-SARS-CoV-2 S Elecsys E2G 300 Elecsys Anti-SARS-CoV-2 S 07613336180679 Reagents, kits 300 tests cobas e 402/801 true 09289267190 Anti-SARS-CoV-2 S Elecsys cobas e 200 Elecsys Anti-SARS-CoV-2 S 07613336180662 Reagents, kits 200 tests cobas e 411/601/602 true 09289275501 Elecsys Anti-SARS-CoV-2 S en 3 FF0000000554960E FF000000046E970E 09289275190 2497 cobas e 801 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useElecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary. False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en 09289275501 Elecsys Anti-SARS-CoV-2 S en 1 FF000000046E970E FF000000046E960E 09289275190 2497 cobas e 801 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useElecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 spike (S) protein receptor binding domain (RBD) in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose acute SARS‑CoV‑2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary. False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en 09289267501 Elecsys Anti-SARS-CoV-2 S en 3 FF0000000554950E FF000000046E780E 09289267190 618 cobas e 411 2325 cobas e 602 619 cobas e 601 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useElecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary. False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en