Respiratory Test Kit Tyfast Flu A+B / COVID-19 Multiplex Rapid Test 25 Tests

Key Features

SKU: CDX-ACT21001-25
Condition: Factory New
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MFR: CorDx Inc Ships from MFI Medical
MPN: ACT21001-25

$228.41

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Description

The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization:
Product ships with minimum 90 days dating
The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
The test provides an efficient and accurate diagnostic solution in 10 mins, giving healthcare providers and communities a rapid and reliable way to prioritize their health
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high or waived complexity tests
This test 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
Results are for the simultaneous in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens
Positive results do not rule out bacterial infection or co-infection with other viruses
Negative results do not rule out influenza or SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with each respiratory infection
Patient Population: The test is designed for individuals aged 2 years and older with symptoms of COVID-19 and/or influenza A and B within the first 5 days of symptom onset

Product Specs

Item Number	1265432
Catalog Number	ACT21001-25
UOM	BX
Level 1 Family Description	Lab-Waived Lab
Level 2 Category Description	Lab-Respiratory Testing
Level 3 Group Description	Combo Tests
Level 4 Sub-Category Description	Combo - Visually Read
Application	Respiratory Test Kit
Brand	Tyfast
Buy American Act (BAA) Compliant	Yes
Contents 1	(25) Test Cassettes, (25) Swabs, (25) Tubes with Sample Processing Solution, IFU, Quick Ref Guide
Country of Origin	United States
Manufacturer	CorDx Inc
Manufacturer #	ACT21001-25
McKesson #	1265432
Number of Tests	25 Tests
Purchase Program Type	Standard Purchase
Reading Type	Visual Read
Sample Type	Anterior Nasal Swab Sample
Specialty	Immunoassay
Test Format	Cassette Format
Test Kit Type	Rapid
Test Method	Lateral Flow
Test Name	Flu A+B / COVID-19 Multiplex Rapid Test
Time to Results	10 Minute Results
Trade Agreement Act (TAA) Compliant	Yes
UNSPSC Code	41116144

Frequently asked questions

Does this test distinguish between different respiratory viruses?

Yes, this is a multiplex diagnostic tool. It is designed for the simultaneous, qualitative detection and differentiation of:

Influenza A
Influenza B
SARS-CoV-2

All results are derived from a single anterior nasal swab specimen.

How quickly can I expect the diagnostic results?

The CorDx Tyfast test is highly efficient, delivering reliable results in just 10 minutes, allowing for rapid patient management decisions.

Is this kit suitable for professional clinical environments?

Yes, this product is authorized for professional in vitro diagnostic use only. It is intended for use in laboratories certified under CLIA for waived, moderate, or high-complexity testing.

Which specific viral proteins does this test target?

The test identifies specific viral antigens using a lateral flow immunochromatographic assay. Specifically, it targets:

Influenza A and B nucleoprotein antigens
SARS-CoV-2 nucleocapsid antigen

What is the recommended window for patient testing?

For optimal performance, the test is calibrated for use on individuals who are exhibiting symptoms of respiratory infection within the first 5 days of symptom onset.

Is this product manufactured in the United States?

Yes, the CorDx Tyfast Multiplex Rapid Test is made in the USA and is both Buy American Act (BAA) and Trade Agreement Act (TAA) compliant.

Are all necessary supplies included in the kit?

Each 25-test kit is fully equipped for clinical use and includes:

25 Test Cassettes
25 Swabs
25 Tubes with Sample Processing Solution
Instructions for Use (IFU)
Quick Reference Guide

Can this be used on very young children?

The test is intended for use on individuals aged 2 years and older who are presenting with symptoms of a respiratory infection.

How should negative test results be interpreted?

Negative results should be interpreted in the context of the patient’s clinical history, recent exposures, and medical evaluation, rather than serving as the sole basis for treatment or patient management decisions.

Does a positive result rule out other infections?

No. Please note that a positive result for one of the detected viruses does not exclude potential bacterial or other viral co-infections.