BD Veritor System For Rapid Detection Of SARS-CoV-2

The BD Veritor System for Rapid Detection of SARS-CoV-2 is a chromatographic digital immunoassay designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens. This test is intended for use by healthcare providers in individuals suspected of COVID-19, both symptomatic (within the first 5 days of symptom onset) and asymptomatic, when tested in a specific sequence over several days. It is authorized for use at the Point of Care (POC) in settings with CLIA certification, whether for waived, moderate, or high complexity testing.

This system does not differentiate between SARS-CoV and SARS-CoV-2 but is intended to identify SARS-CoV-2 nucleocapsid protein antigen, generally detectable during the acute phase of infection. Positive results indicate the presence of viral antigens but should be interpreted alongside clinical history and other diagnostic information to assess the patient's infection status. They do not rule out bacterial infections or co-infections with other viruses, and the detected agent may not be the definitive cause of disease. All results must be reported to the appropriate public health authorities.

Negative results are considered presumptive, and if necessary for patient management, confirmation with a molecular assay may be performed. Negative results should not be the sole basis for treatment or patient management decisions, including infection control measures. These results should be evaluated in the context of the individual's recent exposures, history, and clinical symptoms consistent with COVID-19.

The BD Veritor System employs a dedicated opto-electronic interpretation instrument and immunochromatographic assays. It is designed to detect SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection or those undergoing serial testing. When specimens are processed, the SARS-CoV-2 antigens bind to antibodies conjugated to detector particles on the test strip. The antigen-conjugate complexes migrate to the reaction area and are captured by antibodies on the membrane. The BD Veritor Plus Analyzer determines a positive result when the antigen-conjugate is deposited at both the Test "T" and Control "C" positions on the device, analyzing and correcting for non-specific binding to provide an objective result.

Features:

• Requires reporting of all results to public health authorities.
• Intended for use by healthcare professionals in point-of-care settings.
• Authorized for emergency use under the FDA’s Emergency Use Authorization.
• Provides objective results using opto-electronic interpretation, minimizing subjectivity in result reading.

Kit Includes:

• (30) Single-use Test Devices
• (30) Single-use Reaction Tubes
• (30) Sterile Single-use Specimen Sampling Swabs
• Positive SARS-CoV-2 Control Swab
• Negative SARS-CoV-2 Control Swab
• Instructions for Use
• Quick Reference Card
• Nasal Sampling Instructions

Warnings and Precautions:

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
• For in vitro diagnostic use.
• For prescription use only.
• In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
• Serial testing should be performed in individuals with negative results at least twice over 3 days (with 48 hours between tests) for symptomatic individuals and three times over 5 days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
• If you have had symptoms longer than 5 days, you should consider testing at least three times over 5 days with at least 48 hours between tests.
• Do not use this kit beyond the expiration date printed on the outside carton.
• The test device should remain in its original sealed pouch until ready for use. Do not use if any of the test kit components or packaging is damaged. Once opened, the test device must be used within 5 minutes.
• Do not use the kit to evaluate patient specimens if either the positive control swab or negative control swab fail to give expected results.
• Test results are not meant to be visually determined. All test results must be determined using the BD Veritor Plus Analyzer.
• When using the “Analyze Now” mode, do not read test results before 15 minutes or after 20 minutes. Results read before 15 minutes and after 20 minutes may lead to false positive, false negative or invalid result.
• To avoid erroneous results, specimens must be processed as indicated in the assay procedure section.
• Test components are single use. Do not reuse any BD Veritor System test device or kit components.
• Do not use components from any other BD Veritor test with the BD Veritor System for Rapid Detection of SARS-CoV-2. While components from other BD Veritor tests may appear similar, they are not the same.
• When collecting the direct anterior nasal swab sample, use the nasal swab supplied in the kit. Do not touch the swab tip.
• Other than the swabs used for specimen collection, kit components should not make contact with the patient.
• Proper specimen collection, storage and transport are critical to the performance of this test.
• The test is intended to be used with direct anterior nasal swabs and is not validated for use with swabs in viral transport media.
• Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated. Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
• Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and disposing of all specimens and all items contaminated with blood or other body fluids.
• The SARS-CoV-2 positive control swabs have been prepared from recombinant viral proteins and do not contain infectious material.
• Dispose of used BD Veritor System test devices and reagents as biohazardous waste in accordance with federal, state and local requirements. Reagents contain sodium azide, which is harmful if inhaled, swallowed or exposed to skin. If there is contact with skin, wash immediately with plenty of water. Contact with acids produces very toxic gas. Dispose of used BD Veritor System test devices and reagents in accordance with federal, state and local requirements in an approved biohazard waste container. Do not flush reagents down the drain.
• Do not inhale, swallow or ingest any kit components. Avoid contact with your skin and eyes. The reagent solution contains harmful chemicals (see Hazardous Ingredients Table 1 below). If the solution contacts your eyes, flush with large amounts of water. If irritation persists, seek medical advice

Storage:

Kits may be stored at 2–30 °C. DO NOT FREEZE. Reagents and devices must be at room temperature (15–30 °C) when used for testing.

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

Please call us for specific details.