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Healgen Covid-19 IgG/IgM Rapid Test Corona V Antibody 25/Box

Healgen Covid-19 IgG/IgM Rapid Test Corona V Antibody 25/Box

Code: GCCOV-402A
Shipping Weight: 2.00 pounds
 IN STOCK! 

APPROVED BY FDA FOR EMERGENCY USE  (FDA/EUA) 

FOR USE BY CLIA APPROVED LABORATORY FACILITIES (Moderate & Highly Complex Rated)

HEALGEN :  IgG/IgM Corona Virus Rapid Antibody Test

A rapid (10 minute) Cassette Test for the qualitative detection of IgG and IgM antibodies to 2019-nCov in human whole blood, serum, plasma specimens.  Finger stick samples can be used for specimens collection.

Warning Statement:
  • Results from Antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains or other interference factors.
  • Not for the screening of donated blood.
For Sale only to Physicians, Medical Practices.  NOT FOR HOME USE.

Corona Virus Covid-19 antibody test kits for professional medical use only

·       This is NOT a home Coronavirus test kit and is for professional medical use only.

·       To order Covid-19 antibody test kit you must be a licensed Medical Facility with an NPI registry number

·       We may contact you prior to sending orders to verify your details.

25 x Healgen GCCOV-402A  Rapid 2019-nCov (Covid-19) IgG / IgM on-site Coronavirus test kit.

·       Rapid Covid-19 whole blood/serum/plasma test cassette

·       Qualitative lateral flow immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV

·       Individual results for IgM and IgG detection

·       For professional in vitro diagnostic use only

·       This is a professional only medical diagnostic test kit intended solely for use by healthcare professionals under the supervision of doctors.

·       Storage at 2-30*C  (36-86F) (accelerated stability studies suggest 24-month expiry stability)

·       Compared to commercial PCR,  offers a relative sensitivity of 100% for IgG and IgM. The relative specificity is 97.5% combined for IgG and IgM

·       No Cross-reactivity with Influenza A, B, RSV or Adenovirus

·       Suitable for whole blood, serum, or plasma.

·       Results can be read at 10 minutes

Limitations

·       The Healgen GCCOV-402a screens for antibodies specifically produced against Covid-19 and NOT virus antigenic material. A negative test result does NOT exclude Covid-19 infection.

·       Interpretation of results must always be interpreted with consideration to the other clinical presenting information and should not be used as the sole criteria for the diagnosis of 2019-nCoV infection.

·       Clinical studies have shown IgM is detectable at 3-5 days after the initial infection. This corresponds to the onset of clinical symptoms in some patients. Antibody reactions can be delayed, making this test an incomplete determinant for use in the acute diagnosis of active infection. 

·       The role of this test can also be used to identify recovered patients, confirming they have had previous COVID-19 exposure and responded with antibody production.

·       IgG antibodies are detectable 4-10 days after the onset of clinical symptoms.

·       Where access to PCR antigen testing is not available, negative tests should be repeated in 72 hours where clinical symptoms persist.

·       Not for screening of donated blood.  

Coronavirus Covid-19 Test pack contents

·       25 Covid-19 test cassettes

·       25 Blood dropper pipettes

·       1 data sheet instruction for use insert

·       1 vial buffer solution to run tests with whole blood samples

Items Not Included that may be needed to perform Testing:

·       Timer

·       Finger Stick Lancets·       

·       Alcohol Preps

·       Bandages





Price: $300.00
Quantity Ordered: none
Quantity:
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