McKesson Consult® COVID-19 / Flu A&B Antigen Test, Professional, CLIA Waived, 25 Tests/BX is a lateral-flow immunochromatographic assay designed for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and Influenza A and B nucleoprotein antigens from anterior nasal swab specimens.

The professional-use test simultaneously evaluates COVID-19, Flu A, and Flu B using one collected specimen and provides visual results in approximately 15 minutes. McKesson identifies the test as CLIA Waived and suitable for professional testing of individuals 2 years of age and older. Each box includes 25 test cassettes, sterile nasal swabs, pre-filled extraction tubes, extraction tips, tube holders, Instructions for Use, and Quick Reference Instructions.

Key Features

McKesson identifies the test as CLIA Waived, professional-use, anterior-nares sampling, visual-read, cassette-format, and a lateral-flow immunochromatographic assay.

Kit Contents – BX/25 Tests

Each box contains:

McKesson confirms this exact kit configuration for MPN 535-COVFLUPOC.

Material Required but Not Included

Timer or clock

The current IFU identifies a timer or clock as required but not supplied.

Performance Snapshot

McKesson publishes the following clinical agreement values:

These are PPA/NPA values from the manufacturer's clinical comparison, not claims of absolute sensitivity or specificity.

Specifications

McKesson confirms CLIA-waived status, country of origin, BAA/TAA status, 25-test configuration, ≥90-day acceptable dating, test methodology, specimen type and UNSPSC.

The current professional IFU confirms in-vitro diagnostic/professional use, anterior nasal specimens, age parameters and storage requirements.

External Controls

External controls are not included in MPN 535-COVFLUPOC.

The compatible external control set is:

McKesson Consult® External Controls – MPN 535-PN2

Contents:

• 1 Positive Control Swab

• 1 Negative Control Swab

• External Control Instructions for Use

The current IFU recommends quality-control testing in professional healthcare environments, including for a new lot, new shipment, untrained operator, and according to internal or regulatory quality procedures.

Storage & Stability

Storage

36–86°F / 2–30°C

Store away from direct sunlight.

Before Testing

Test devices and reagents should be brought to:

59–86°F / 15–30°C

Open Cassette

Use promptly after opening.

The current IFU states that an unsealed cassette is valid for approximately 1 hour and should preferably be used immediately.

Test Procedure – Catalog Summary

1. Collect an anterior nasal specimen using the supplied sterile swab.

2. Swab each nostril according to the IFU.

3. Process the swab in the supplied extraction buffer.

4. Apply the required specimen drops to the test cassette.

5. Read results at 15–20 minutes.

6. Do not interpret results before 15 minutes or after 20 minutes.

The complete manufacturer IFU should always control actual clinical use.

Important Result Interpretation

Negative Results

Negative results are presumptive and do not rule out COVID-19, Influenza A, Influenza B, or other respiratory infections. Molecular confirmation may be appropriate based on clinical judgment.

Positive Results

Positive results indicate detection of the corresponding viral antigen but do not exclude co-infection with other respiratory pathogens.

Warnings

The IFU also warns that the extraction reagent can cause skin and eye irritation and should be handled according to the manufacturer's safety instructions.

• Sterility
  Sterile
• Single Patient
  Yes
• Autoclave Ready
  No