COVID19 rapid test: Asure Antibody test, The ‘ONLY‘ EUA POC/CLIA Waived
POC authorization, what does that mean?
This test can be performed and results within 15 mins. Our POC authorized finger stick blood samples can be tested in point of care settings. For example Urgent care centers, doctor’s offices, walk-in clinics, drug and alcohol rehabs, detox, hospitals emergency rooms.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under a 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; and
- 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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Covid19 rapid test: POC authorization, what does that mean?
This test can be performed and results within 15 mins. Our POC authorized finger stick blood samples can be tested in point of care settings. For example Urgent care centers, doctor’s offices, walk-in clinics, drug and alcohol rehabs, detox, hospitals emergency rooms .This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Device: Assure COVID-19 IgG/IgM Rapid Test Device
Company: Assure Tech.
Indication: 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. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Included in Covid19 test kit:
- Individually Packed Test Device
- Disposable Pipettes
- Package Insert
Covid-19 testing in bulk
Coronaviruses are a large family of viruses that are common in many different species of animals including camels, cattle, cats, and bats.
The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause a severe respiratory syndrome in humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43 and HKU1) induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause severe infections in infants, young children, and elderly individuals1,2,3. COVID-19 is the disease associated with SARS-CoV-2, which was identified in China at the end of 2019.
Coronaviruses cause respiratory and intestinal infections in animals and humans. The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The incubation period for COVID-19 is currently estimated at between two and 14 days.
Common symptoms of COVID-19 infection include fever, cough, and respiratory symptoms such as shortness of breath and breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the death of the patient.
People with existing chronic conditions seem to be more vulnerable to severe illness. Detection of IgM indicates a recent infection and can be used for early diagnosis of infection. IgG antibodies gradually appear and increase in the late stage of infection, and the COVID19 Rapid Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody.
How does it work?
FDA Authorizes First Point-of-Care Antibody Test for COVID-19 Approved September 23, 2020 Submission number EUA200487
The COVID19 Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibodies through visual interpretation of color development.
Anti-human IgG and anti-human IgM are used to detect specific antibodies in the human whole blood, serum, or plasma specimen. When a specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad.
As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particles are captured in the internal control region.
The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.
Relative sensitivity: 93.7%
Relative specificity: 99.1%
Overall agreement: 97.7%
*95% Confidence Interval
Relative sensitivity: 98.8%
Relative specificity: 98.7%
Overall agreement: 98.7%
*95% Confidence Interval
Covid-19 IgG/IgM Rapid Test Instructions for Use
Allow the Covid19 rapid test device, specimen, buffer, and/or controls to reach room temperature 59F-86F (15-30°C) prior to testing.
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- lace 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.
- Label the test with patient or control identification.
- Add the specimens. sing the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of the 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.
- Wait for the blue line change to red line, read results at 15 minutes. Note: Specimens can also be applied using a micropipette.
COVID Testing Results interpretation
Covid19 rapid test: Covid Test Results
For IgM detection:
|COVID-19 IgG/IgM Rapid Test||IgM+||74||2||76|
For IgG detection:
|COVID-19 IgG/IgM Rapid Test||IgG+||82||3||85|
04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
Audience: Clinical Laboratory Professionals
Level: Laboratory Update
FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19 testing, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.
In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorizationexternal icon. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.
For more information, visit this FDA Web pageexternal icon, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.
- Clinical Laboratory Improvement Amendments (CLIA)
- Clinical Laboratory Covid19 rapid test Response Weekly Calls
- CDC COVID-19 Information for Laboratories
- CDC COVID-19 Website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address to sign up.
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)