- Condition: Factory New
- Weight: 0.92 lb
- Sofia 2 analyzer with Advance Result Technology (ART) delivers accurate, objective and automated results in 3 – 15 minutes, allowing Lyme testing to be performed in near-patient testing environments.
- Easy to use and dispose of with clean self-contained test cassette.
- One test, one finger-stick whole blood sample provides differentiated IgM and IgG results.
- Box contains 15 individually packaged test cassettes, 15 blood collection preparation kits, bottle positive control, bottle negative control, package insert, quick reference instructions and QC card.
-
Learn more:
- MFR: Quidel Ships from MFI Medical
- MPN: 20319
Frequently asked questions
Does this test provide quick diagnostic results?
Yes, the Sofia 2 Lyme Disease Test is designed for efficiency and delivers results in approximately 10 minutes, allowing for rapid clinical decision-making.
Are both IgM and IgG results detected?
Absolutely. This test kit is capable of providing both IgM and IgG results from a single whole blood sample, ensuring a comprehensive assessment.
Is the test kit compatible with existing analyzers?
This kit is specifically engineered for professional use with the Sofia or Sofia 2 Analyzer systems to ensure consistent and precise machine-read results.
Does this test require specialized refrigeration storage?
No, this kit offers excellent operational flexibility as it is designed for convenient room temperature storage, saving valuable refrigerated space.
Is this kit suitable for CLIA-waived settings?
Yes, this product is CLIA Waived for Fingerstick Whole Blood. Please note that a valid Certificate of Waiver is required to perform these tests in a CLIA-waived professional setting.
What items are included in the complete kit?
Each 15-test kit arrives fully equipped with:
- 15 Individually packaged test cassettes
- 15 Blood collection preparation kits
- Positive and negative control bottles
- Instructional package insert, quick reference guide, and QC card
Is the test manufactured to high quality standards?
Yes, this product is proudly manufactured in the United States and is both BAA (Buy American Act) and TAA (Trade Agreements Act) compliant.
Does the system support different testing volumes?
Yes, the Sofia 2 platform features dual work modes, which are designed to accommodate varying testing volumes to support efficient clinical workflows.
How is the testing accuracy ensured?
Accuracy is maintained through the fluorescence immunoassay (FIA) lateral flow method, which provides objective, machine-read results rather than relying on manual visual interpretation.
Is this test appropriate for urgent care environments?
This test is specifically optimized for professional medical environments, including urgent care facilities, clinical laboratories, and professional healthcare settings that require rapid infectious disease screening.