- Condition: Factory New
- Country of Origin: USA
- Warranty: Until Use/Expiration
- Weight: 1.37 lb
- Flocked nasopharyngeal swab provides superior specimen collection and patient comfort
- Visually read results in just 15 minutes
- Health Canada approved
- Approved under FDA Emergency Use Authorization (EUA)
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from MFI Medical
- MPN: 33225
- Phone: (800) 526-2125
Frequently asked questions
Is a comfortable flocked swab included?
Yes, the kit includes a specialized, sterile flocked nasopharyngeal swab. This design is specifically engineered to enhance the collection process while prioritizing patient experience.Key benefits of the flocked swab include:* Superior Specimen Collection: The material is optimized for retrieving an adequate sample, supporting the test’s high performance metrics.* Enhanced Patient Comfort: The design helps minimize discomfort during the anterior nasal or nasopharyngeal specimen acquisition process.
Does this diagnostic test offer rapid results?
Yes, the LifeSign Status Immunoassay is designed to provide rapid results in a clinical setting. The test delivers visually readable results in as little as 15 minutes, which is crucial for timely diagnosis and management of COVID-19, Influenza A, and Influenza B.
Does this rapid test have high sensitivity and specificity?
Yes, the LifeSign Status rapid immunoassay demonstrates strong analytical performance across all three targets (COVID-19, Flu A, and Flu B).
The key clinical performance metrics are as follows:
- COVID-19 (SARS-CoV-2):
- Sensitivity: 93.9%
- Specificity: 100.0%
- Influenza Type A (Flu A):
- Sensitivity: 91.4%
- Specificity: 95.7%
- Influenza Type B (Flu B):
- Sensitivity: 87.6%
- Specificity: 95.9%
Is the 25-test kit complete with all needed components?
Yes, the LifeSign Status COVID-19/Flu A&B Rapid Immunoassay kit is a complete, factory-new package designed to perform 25 simultaneous diagnostic tests for COVID-19, Flu A, and Flu B.
The box contains everything necessary for immediate use in a professional lab setting, including:
- 25 Test devices
- 25 Extraction reagent capsules
- 25 Sterile flocked nasopharyngeal swabs (engineered for superior specimen collection)
- 1 Positive control swab
- 1 Negative control swab
- 1 Package insert
- 1 Procedure card
Does this rapid immunoassay have regulatory approvals?
Yes, the LifeSign Status COVID-19/Flu A&B Rapid Immunoassay holds significant regulatory authorizations, including Health Canada approval and FDA Emergency Use Authorization (EUA). This confirms its validity for use in professional clinical settings.
Are control swabs included for reliable testing?
Yes, the kit is designed for professional quality assurance and includes both a positive control swab and a negative control swab. These components help validate the test procedure, ensure reagent integrity, and confirm reliable results during clinical use.
Are these tests suitable for home or self-administration?
No, this is a professional-grade diagnostic kit strictly intended for use in clinical laboratory, urgent care, or point-of-care settings.
Because of its professional nature:
- Required Documentation: A CLIA number is mandatory at the time of purchase.
- Administration: It must be performed by trained medical personnel.
- Policy: Due to regulatory and medical standards, these orders are non-cancellable and non-returnable.
Can this test simultaneously detect multiple viruses?
Yes, this rapid immunoassay’s primary advantage is its capability for simultaneous detection of antigens for three major respiratory viruses, streamlining the diagnostic process. Using a single specimen and test device, it rapidly screens for:
- COVID-19 (SARS-CoV-2)
- Influenza Type A (Flu A)
- Influenza Type B (Flu B)
This provides essential differential diagnosis information, with visually readable results available in just 15 minutes.
Which specimen types are compatible with this test?
This rapid immunoassay is designed for use with anterior nasal swab or nasopharyngeal swab specimens.
Is a CLIA number required for this professional test?
Yes, the LifeSign Status COVID-19/Flu A&B Rapid Immunoassay is strictly intended for professional use in a laboratory or clinical setting. It is not an at-home test.
To comply with regulations and place an order, the following is required:
- Physician’s licensing
- A valid CLIA (Clinical Laboratory Improvement Amendments) number
This assay must be performed in a CLIA-certified facility.