Immunoassay Control Set LumiraDx SARS-CoV-2 Ag Positive Level / Negative Level 4 X 0.5 mL

Immunoassay Control Set LumiraDx SARS-CoV-2 Ag Positive Level / Negative Level 4 X 0.5 mL 
Key Features
  • SKU: LDX-L016080109002

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Description

  • The LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY:
  • 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
  • The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses
  • Negative results, from patients with symptoms onset beyond twelve days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • The LumiraDx SARS-CoV-2 Ag Quality Controls (hereafter referred to as Quality Controls) are liquid quality controls to be used with the LumiraDx Instrument (hereafter referred to as the Instrument) and the LumiraDx SARS-CoV-2 Ag Test (hereafter referred to as SARS-CoV-2 Ag Test)
  • The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip
  • The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument
  • Kit contents: 2 X 0.5ml vial SARS-CoV-2 Ag Positive Control, 2 X 0.5ml vial SARS-CoV-2 Ag Negative Control, 24 Transfer pipettes (20µl), LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert
  • Requires: LumiraDx Instrument, LumiraDx SARS-CoV-2 Ag Test Strips, and LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)

Product Specs

Item Number 1176896
Catalog Number L016080109002
UOM EA
Level 1 Family Description Lab-Non-Waived Lab
Level 2 Category Description Lab-Immunoassay
Level 3 Group Description Immunoassay Reagents
Level 4 Sub-Category Description COVID - IA Cals/Ctrls
Application Control Set
Brand LumiraDx
Buy American Act (BAA) Compliant No
Container Type Vial
Country of Origin Unknown
For Use With For use in Conjunction with the LumiraDx SARS-CoV-2 Ag Test Strip System on the LumiraDx Instrument
Form Liquid
Levels Positive Level / Negative Level
Manufacturer LumiraDx Inc
Manufacturer # L016080109002
McKesson # 1197712
Storage Requirements Requires Refrigeration
Test Category Respiratory
Test Name SARS-CoV-2 Ag
Test Type Immunoassay
Trade Agreement Act (TAA) Compliant No
UNSPSC Code 41116128
Volume 4 X 0.5 mL

Frequently asked questions

Is this control set for professional use only?

Yes, this product is strictly intended for professional use in clinical laboratories and point-of-care settings by trained personnel. It is designed to assist facilities operating under CLIA-certified conditions in maintaining rigorous diagnostic standards.

Does this require special storage conditions?

Yes, to maintain the integrity and performance of the liquid controls, this product requires refrigeration.

Is this compatible with the LumiraDx SARS-CoV-2 Ag Test?

Yes, this control set is specifically engineered for seamless integration with the LumiraDx Instrument and LumiraDx SARS-CoV-2 Ag Test Strips.

Why is it necessary to use these controls?

Using validated positive and negative controls is essential for system performance verification. It ensures that your testing system is functioning correctly and provides accurate, reliable results according to established diagnostic standards.

Can this be used for patient management decisions?

While this control set is vital for validating the integrity of your testing system, it is intended for quality assurance only. Clinical correlation remains necessary for all patient management decisions.

What specifically is included in the kit?

The kit is a complete diagnostic solution containing:

  • 2 vials (0.5 mL each) of SARS-CoV-2 Ag Positive Control
  • 2 vials (0.5 mL each) of SARS-CoV-2 Ag Negative Control
  • 24 precision transfer pipettes (20µl) for accurate sample delivery
  • Official product pack insert
Do I need extra equipment to use these?

No extra equipment is required for the application process itself. The kit includes 24 dedicated 20µl transfer pipettes, ensuring you have the necessary tools to perform standardized quality control testing immediately upon receipt.

Is this set suitable for connectivity reporting?

If your facility requires specific connectivity reporting, it is recommended to use this control set in conjunction with LumiraDx Connect.

Are there enough pipettes for multiple tests?

Yes, the kit comes with 24 transfer pipettes, providing an ample supply to perform multiple quality control checks using the included positive and negative control vials.

Is this a standardized diagnostic product?

Yes, it is a professional-grade tool manufactured by LumiraDx Inc. designed specifically to help clinical environments maintain standardized diagnostic accuracy for SARS-CoV-2 Ag testing.