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The BD Veritor™ System for SARS-CoV-2 is a chromatographic digital immunoassay for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BD Veritor™ System for SARS-CoV-2 and followed up with a molecular test. A negative test result is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established between April 2024 and August 2024 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The BD Veritor™ System for SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in anterior nasal swab specimens taken from patients with signs and symptoms of upper respiratory infection (i.e., symptomatic) who are suspected of COVID-19 by their healthcare provider. The test is intended for use with an opto-electronic interpretation instrument, the BD Veritor™ Plus Analyzer Instrument and is not interpreted visually. - When specimens are processed and added to the test device, SARS‑CoV‑2 antigens present in the specimen bind to biotinylated antibodies and antibodies conjugated to detector particles in the test strip. - The biotinylated antibody‑antigen‑conjugate complexes migrate across the test strip to the reaction area and are captured by a line of streptavidin bound on the membrane. - A positive result is determined by the BD Veritor™ Plus Analyzer when antigen‑conjugate is deposited at the Test "T" position and a control conjugate is deposited at the Control "C" position on the assay device. - The instrument analyzes and corrects for non‑specific binding and detects positives not recognized by the unaided eye to provide an objective result. Procedures to evaluate test devices depend on the BD Veritor™ Plus Analyzer workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of a BD Veritor™ Plus Analyzer to a printer or IT system is possible if desired. Additional result documentation capabilities are possible with the integration of a BD Veritor™ barcode scanning enabled module. The Analyzer uses a proprietary algorithm that subtracts the nonspecific signal at the negative control line from the signal present at the test line. If the resultant test line signal is above a preselected cutoff, the specimen is scored as positive. If the resultant test line signal is below or equal to the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The Analyzer measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during the test interpretation as the reflectance value is compared to that of the control and test zones.

The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BinaxNOW COVID-19 Ag Card and followed up with a molecular test. A negative test is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The BinaxNOW COVID-19 Ag Card is an immunochromatographic membrane assay that uses antibodies to detect SARS-CoV-2 nucleocapsid protein from anterior nasal swab specimens. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card. To perform the test, an anterior nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the SCoV-2 Ag Detect Rapid Test and followed up with a molecular test. A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens.

The Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs specimens from individuals with signs and symptoms of upper respiratory infection within the first six (6) days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Healgen Rapid COVID-19 Antigen Test and followed with a molecular test The test does not differentiate between SARS-CoV and SARS-CoV-2. A negative test result is presumptive and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions. Positive results do not rule out co-infection with other respiratory pathogens Performance characteristics for SARS-CoV-2 were established from May 2022 to July 2022 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 virus in nasal swab collected specimens. The test strip is composed of the following components: sample pad, reagent pad, reaction membrane, and absorbing pad housed within a test cassette. The reagent pad contains colloidal-gold-conjugated monoclonal antibody that recognizes and binds to the nucleocapsid protein of SARS-CoV-2; the reaction membrane in the test line (T) contains the second antibody that recognizes another epitope of the nucleocapsid protein of SARS-CoV-2. External quality controls are required but not included with the test kit and are sold separately as the COVID-19 Antigen Control Kit. The control swabs should be processed according to the Instructions for Use (IFU) and are intended to be used as quality control samples to demonstrate that the test is performing and is being performed correctly.

The Nano-Check™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Nano-Check™ COVID-19 Antigen Test and followed up with a molecular test. The test does not differentiate between SARS-CoV or SARS-CoV-2. A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the 2022-2023 SARS-CoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The Nano-Check™ COVID-19 Antigen Test is an immunochromatographic assay for detection of extracted SARS-CoV-2 nucleoprotein antigens in human anterior nasal swab specimens. The assay kit consists of 20 test cassette devices, 20 reagent tubes containing extraction buffer for Set A or 20 empty reagent tubes and 20 ampules containing extraction buffer for Set B, 20 anterior nasal specimen collection swabs, one positive control swab, one negative control swab and an Instructions for Use/Quick Reference Instruction. An external positive control swab is used with recombinant SARS-CoV-2 nucleocapsid dried onto the swab and an external negative control swab contains blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

The Sofia 2 SARS Antigen+ FlA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and followed up with a molecular test. The test does not differentiate between SARS-CoV and SARS-CoV-2. A neqative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with bacteria or other viruses and should not be used as the sole basis for treatment or other patient management decisions. Performanc characteristics for SARS-CoV-2 were established during the 2021-2022 SARS-CoV-2 pandemic when SARS CoV 2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variant are emerging, performance characteristics may vary. This test is intended for prescription use only and can be used in Point-of-Care settings. Sofia 2 SARS Antigen+ FIA Control Swab Set: The Sofia 2 SARS Antigen+FIA Control Swabs are intended to be used as quality control samples with the Sofia 2 SARS Antigen+ FIA and are representative of positive and negative test samples. These Controls may be used to demonstrate that the reagents and assay procedure perform properly.

The Sofia 2 SARS Antigen+FIA is based upon a lateral flow technology that employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from the SARS-CoV-2 virus in human anterior nasal swab specimens. The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. The Test Strip is composed of the following biochemical components dried and immobilized onto the nitrocellulose membrane: 1) sample pad that receives the specimen: 2) a label pad that contains detection fluorescent micro-particles, coated with monoclonal antibodies that are specific for SARS-CoV-2 nucleocapsid antigen; 3) embedded monoclonal antibodies specific for SARS-CoV-2 nucleocapsid antigen to capture the antigen-microparticle complex at the tocation. The sample pad facilitates migration of the sample fluid across the nitrocellulose strip into the absorbent pad (See Figure 4-1 in attachment). The test strip also contains a desiccant that does not participate in the assay but serves as a stabilizing agent during storage. Sample is applied to in the sample well and migrates through a test strip, then passes through the test and control lines. If SARS-CoV-2 viral antigen is present, they will be bound by the fluorescent microparticles io the label pad reqion, forming an antigen-microparticle complex. The test line is coated with monoclonal antibodies that are specific to SARS-CoV-2 nucleocapsid antigen and is intended to capture the antigen-microparticle complex. If SARS-CoV-2 viral antigen is not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2. The Sofia 2 SARS Antigen+ FIA employs antibody tagged microparticles dyed with a fluorescent compound, to be detected and read by the Sofia 2 reader instrument. The Sofia 2 analyzers automatically scan/image the test strip, collect and analyze the fluorescence data, and report the result as either positive, negative, or invalid. Additionally, the Sofia 2 Antigen+ FIA utilizes a reference line for the Sofia 2 reader (to locate the test line and negative control line) and a procedural control (to assess for sample presence and adequate sample flow). No colored lines will be visible in the test window of the fluorescent assay cassette, thereby preventing visual interpretation of the test results. The operator must use the Sofia 2 analyzer to obtain a test result. The Sofia 2 SARS Antigen+ FIA Control Swabs are intended to be used as quality control samples representative of positive and neqative test samples, to demonstrate that the reagents are that the assay procedure is correctly perform.

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests. The test does not differentiate between SARS-CoV and SARS-CoV-2. A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions. Positive results do not rule out co-infection with other respiratory pathogens. Performance characteristics for SARS-CoV-2 were established during the 2021-2022 SARS-CoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variant are emerging, performance characteristics mav vary. This test is intended for prescription use only and can be used in Point-of-Care settings.

The Sofia 2 SARS Antigen+FIA is based upon a lateral flow technology that employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from the SARS-CoV-2 virus in human anterior nasal swab specimens. The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. The Test strip is composed of the following biochemical components dried and immobilized onto the nitrocellulose membrane: 1) sample pad that receives the specimen; 2) a label pad that contains detection fluorescent micro-particles, coated with monoclonal antibodies that are specific for SARS-CoV-2 nucleocapsid antigen: 3) embedded monoclonal antibodies specific for SARS-CoV-2 nucleocapsid antigen to capture the antigen-microparticle complex at the test line location. The sample pad facilitates migration of the sample fluid across the nitrocellulose strip into the absorbent pad. The test strip also contains a desiccant that does not participate in the assay but serves as a stabilizing agent during storage. Sample is applied to in the sample well and migrates through a test strip, then passes through the test and control lines. If SARS-CoV-2 viral antigen is present, they will be bound by the fluorescent microparticles in the label pad region, forming an antigen-microparticle complex. The test line is coated with monoclonal antibodies that are specific to SARS-CoV-2 nucleocapsid antigen and is intended to capture the antigen-microparticle complex. If SARS-CoV-2 viral antigen is not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2. The Sofia 2 SARS Antigen+FIA employs antibody-tagged microparticles dyed with a fluorescent compound, to be detected and read by the Sofia 2 reader instrument. The Sofia 2 analyzers automatically scan/image the test strip, collect and analyze the fluorescence data, and then calculate and report the result as either positive, negative, or invalid. Additionally, the Sofia 2 Antigen+ FIA utilizes a reference line for the Sofia 2 reader (to locate the test line and negative control line) and a procedural control (to assess for sample presence and adequate sample flow). No colored lines will be visible in the test window of the fluorescent assay cassette, thereby preventing visual interpretation of the test results. The operator must use the Sofia 2 analyzer to obtain a test result. The Sofia SARS Antigen FIA Control Swabs are intended to be used as quality control samples representative of positive and negative test samples, to demonstrate that the reagents are functional and that the assay procedure is correctly perform.