HEALGEN COVID-19/Flu A&B Ag Combo Rapid Test Cassette Instructions

COVID-19/Flu A&B Ag Combo Rapid Test Cassette

Specifications

• Product Name: External Controls
• Models: REF GCFC-PN2, GCFC-PN20
• Contents:
  • 1 Positive swab
  • 1 Negative swab
  • 10 Positive swabs
  • 10 Negative swabs
• For In Vitro Diagnostic Use
• For Prescription Use Only
• For Professional Use Only
• For Emergency Use Authorization (EUA) Only

Product Usage Instructions

Contents Description:

The positive control swabs contain SARS-CoV-2, Influenza A, and
Influenza B recombinant antigens with Proclin 300 preservative on a
red shaft.

The negative control swabs have negative control buffer with
Proclin 300 preservative on a blue shaft.

Warnings and Precautions:

• For in vitro diagnostic use only.

• Product authorized by FDA under Emergency Use Authorization in
  the USA.

• Do not use after the expiration date.

• The swab should remain in the sealed pouch until use.

Storage and Stability:

Store the product as per the instructions provided in the manual
to ensure stability.

Materials Required:

• Disposable gloves
• Timer
• Prefilled Extraction Tube
• Extraction Tube Tip
• COVID-19/Flu A&B Ag Rapid Test Cassette kit
• Tube holder

Control Kit Test Procedure:

• Avoid eating, drinking, or smoking during the procedure.

• Handle all specimens as potentially hazardous.

• Discard the control swab and test device in a proper biohazard
  container after testing.

• Use the swab within 2 hours of opening the sealed pouch.

Interpretation of Results:

Refer to the user manual for guidance on interpreting the test
results accurately.

FAQ

Q: Can the product be used for self-testing at home?

A: No, the product is for professional use only and must be used
under proper medical supervision.

Q: How should I handle the used swabs after testing?

A: Dispose of the used swabs in a proper biohazard container
following recommended guidelines.

Q: What should I do if I encounter any deviations from the

instructions during product usage?

A: It is crucial to follow the instructions carefully to ensure
reliable assay results. Contact technical support for guidance in
case of any deviations.

External Controls
Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) Instructions for Use

REF GCFC-PN2 GCFC-PN20

CONTENTS

1 Positive swab

1 Negative swab

10 Positive swabs

10 Negative swabs

For In Vitro Diagnostic Use. For Prescription Use Only For Professional Use Only. For Emergency Use Authorization (EUA) Only.

Instructions for use must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions.
INTENDED USE The External Controls – Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a ready-to-use external control kit for use with the Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab). This kit is designed to verify proper test procedure and performance of the COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab).
CONTENTS

The positive control swabs are composed of a SARS-CoV-2 recombinant antigen, Influenza A recombinant antigen and Influenza B recombinant antigen extract dried onto a swab, with a red shaft, containing 0.05% Proclin 300 as a preservative.
The negative control swabs are composed of negative control buffer dried onto a swab, with a blue shaft, containing 0.05% Proclin 300 as a preservative.
External Controls Instructions for Use.

WARNINGS AND PRECAUTIONS
– For in vitro diagnostic use.
– In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has

been authorized only for the detection of proteins from SARS-CoV-2 and influenza A/B, 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.
– Do not use after expiration date. – COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab). Incompatibilities between

– The swab should remain in the sealed pouch until use.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at refrigerated or room temperature (230ºC/36-86ºF). The swab is stable through the expiration date printed on the sealed pouch. The swab must remain in the sealed pouch until use. Do not freeze (below 0ºC/32ºF).
MATERIALS

MATERIALS PROVIDED
– Negative control swab(s) (blue) – Positive control swab(s) (red) – Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED
– Disposable gloves – Timer – Prefilled Extraction Tube – Extraction Tube Tip – COVID-19/Flu A&B Ag Rapid Test
Cassette kit
– Tube holder

CONTROL KIT TEST PROCEDURE
For the complete Test Procedure, refer to these sections in the Instructions For Use of the Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) kit.Healgen® COVID-19/Flu A&B Ag Combo Rapid Test – Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, do not
eat, drink, or smoke in the area. – All the specimens should be considered potentially hazardous and handled in the same
manner as an infectious agent. – The control swab and test device should be discarded in a proper biohazard container
after testing. – The swab must be used within 2 hours of opening the sealed pouch.

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INTERPRETATION OF RESULTS

SYMBOLS

TECHNICAL SUPPORT
Healgen Scientific, LLC. 3818 Fuqua Street, Houston, TX 77047 Phone: +1(713) 733-8088 (8:30 am to 5:00 pm CDT) www.healgen.com

C-06052024-A5-IVD-D11-V4 Revision Date: 2024-06-10

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References

• Healgen

Read User Manual Online (PDF format)

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