BD Veritor System 30 test/kit for Rapid Detection of SARS-CoV-2 (Covid-19)

The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19.

Features

·         Displays easy-to-read digital results for SARS-CoV-2 in 15 minutes

·         Easy operation and 1-button functionality may help reduce the potential for procedural errors.

·         Adapts easily to your workflow with 2 operational modes: Walk Away and Analyze Now.

o   Walk away: Test device is inserted immediately into Analyzer, so staff can multi-task while sample incubates (15 minutes)

o   Analyze now: Test device is inserted after incubation time is complete, allowing batches of samples to be tested (results in seconds)

·         Meet patient and staff needs with simple, timely point-of-care testing.

·         Simple sample processing with color-coded tubes

·         Achieve fast, reliable results

·         Displays easy-to-read digital results for COVID-19 in 15 minutes: “CoV2: +” for positive, “CoV2: -” for negative

·         Records results on secured internal drive

·         Download and display Lot number, patient/specimen ID, Operator ID, and test records with BD Veritor™ InfoScan module

·         Offers result-printing capabilities via USB port

WHY FALSE POSITIVES MIGHT OCCUR

Even the most highly accurate tests can produce false positive results. False positives are expected for all diagnostic tests, involving all detection technologies: PCR, antigen assays, etc. In the case of antigen tests (such as BD Veritor™ Plus System), test results could be influenced by several factors:

·         Workflow inconsistencies

·         Quality of test sample

·         Not following instructions for use

BD Veritor™ Plus System has a 98%-100% specificity, which means the false positive rate is less than 2% of all the tests performed. This means, when you use your BD Veritor™ Plus System you might see 0-2 false positives for every 100 tests you conduct. If a customer sees rates of false positives higher than 2% of all the tests performed, this would be outside of the performance we would expect. Any false positive should be reported to BD for further investigation.

KEY TERMS TO UNDERSTAND WITH COVID-19 TESTING

Understanding the specifics of test performance can be complex. Below is the list of test performance terminology which may help you to better understand.

·         Pretest Probability: Probability of a patient having an infection before the test result is known; based on the proportion of people in a community with the disease at a given time (prevalence) and the clinical presentation of the patient.

·         Negative Predictive Value: Probability that a patient who has a negative test result truly does not have the infection.

·         Positive Predictive Value: Probability that a patient who has a positive test result truly does have the infection.

·         False Positive Result: A test result indicating the infection is present when it is not.

·         True Negative Result: A test result correctly indicating that the infection is not present.

·         False Negative Result: A test result indicating the infection is not present when it is.

·         True Positive Result: A test result correctly indicating that the infection is present.