Cellex COVID-19 coronavirus qSARS-CoV-2 IgG/IgM Rapid Test, FDA approved | | hyppolabor

Cellex COVID-19 coronavirus qSARS-CoV-2 IgG/IgM Rapid Test, FDA approved

Cellex COVID-19 coronavirus qSARS-CoV-2 IgG/IgM Rapid Test, FDA approved

INTENDED USE

The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider. The qSARS-CoV-2 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the qSARS-CoV-2 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. A CLIA categorization of this device would be consistent with other serology lateral flow moderate complexity devices.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the qSARS-CoV-2 IgG/IgM Rapid Test early after infection is unknown.

False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

For prescription use only. For in vitro diagnostic use only. For emergency use authorization use only.

Clinical Performance

Testing of RT-PCR positive clinical specimens:

  • The CELLEX qSARS-CoV-2 IgG/IgM Rapid Test had a Positive Percent Agreement and Negative Percent Agreement of 93.75% (95% CI: 88.06-97.26%) and 96.40% (95% CI: 92.26-97.78%), respectively.
  • Positive Percent Agreement (PPA)= 120/128 (93.8%), 95% CI: 88.2% to 96.8%
  • Negative Percent Agreement (NPA)= 240/250 (96.0%), 95% CI: 92.8% to 97.8%
Testing of RT-PCR positive clinical specimens:

Study of: Venous Whole blood specimens spiked with positive samples

  • Study of Venous Whole blood specimens spiked with positive samples: Fifty (50) negative whole blood samples were spiked with positive serum at 1:100. Another fifty (50) whole blood specimens were spiked with negative serum at the same dilution. These 100 specimens were coded and tested with the qSARS-CoV-2 IgG/IgM Rapid Test. All spiked samples were correctly identified by the test except for one of the negative samples, which was tested positive with the test. Thus, there was a 99% concordance rate with expected results when venous whole blood specimens are used.
tudy of: Venous Whole blood specimens spiked with positive samples

Cellex rapid test details

Catalog#5513C
ApprovalFDA –  Food and Drug Administration
ProductCellex coviud-19 qSARS-CoV-2 IgG/IgM Rapid Test
Kit size25  tests
Price530 eruro + taxes / kit (25 tests)
Minimum order quantity2 kits
Availability In stock / preorder
Shipping1 – 15 days

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Documentation

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