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Ecotest COVID-19 POC Rapid Antibody Test (20/Box) (CLIA WAIVED)
Ecotest COVID-19 POC Rapid Antibody Test (20/Box) (CLIA WAIVED)


 
Our Price: $225.00




Product Code: AZCOVID-19PECO

Enter CLIA or NPI Number



 
Details
 
CLIA certificate of waiver or NPI number is required for this purchase.

Note: This product can only ship to a medical or an educational facility.

The Ecotest COVID-19 IgG/IgM Rapid Test Device is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.


Features and Benefits
  • Rapid results in 15 minutes
  • FDA EUA authorized CLIA waived finger stick whole blood IgM/IgG combination antibody test
  • Small sample volume: only 5 µL of serum/plasma or 10 µL of whole blood
  • Rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.
  • The Ecotest COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Warning
  • This test has not been FDA cleared or approved
  • This test has been authorized by FDA under an EUA for use by authorized laboratories
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
  • This product is intended for professional use and not for home use
  • Not for the screening of donated blood



Materials Included
  • (20) Individually packed test devices
  • (20) Alcohol prep pads
  • (20) Sterile safety lancet
  • (1) Buffer
  • (1) procedure card
  • (1) Package insert
Test Procedure
  • 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible
  • 2. Place the test device on a clean and level surface. Note: There should be a blue line in the control region (next to “C”). Discard the device if there is no blue line
  • 3. Label the test with patient or control identification
  • 4. Add the specimens
  • 5. Wait for the blue line change to red line, read results at 15 minutes
For Serum or Plasma Specimen
  • Using the provided disposable pipette, draw the specimen up to the Fill Line, and transfer all the specimen (appr. 5 µL) into the specimen well of the test device, then add 2 drops of buffer and start the timer.
Plasma Specimen
  • Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 2 drops of buffer and start the timer.


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