COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
Assure, The ‘ONLY’ EUA POC/CLIA Waived COVID19 Antibody 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.
What is Coronavirus?
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 individuals.
What Does the COVID-19 IgG/IgM Rapid Serology Test Device Detect?
The COVID-19 IgG/IgM Rapid Serology Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-s IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of primary and second SARS-COV-2 infections.
- 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.
How to use Covid Test
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IgM Detection:
Relative sensitivity: 93.7%
Relative specificity: 99.1% Overall agreement: 97.7% *95% Confidence Interval |
IgG Detection:
Relative sensitivity: 98.8%
Relative specificity: 98.7% Overall agreement: 98.7% *95% Confidence Interval |
Documentation:
NEWS:
Included Materials:
Product Information:
04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
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, 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.
Additional Resources:
- Clinical Laboratory Improvement Amendments (CLIA)
- Clinical Laboratory COVID-19 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)
Covid-19 IgG/IgM Rapid Serology Test Instructions for Use
- Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
- Place the test device on a clean and level surface.
- (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
- Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
- The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
Clinical Evaluation:
For IgM detection:
| Method | PCR+ | PCR- | Total | |
| COVID-19 IgG/IgM Rapid Test | IgM+ | 74 | 2 | 76 |
| IgM+ | 5 | 225 | 230 | |
| Total | 79 | 227 | 306 | |
For IgG detection:
| Method | Convalescent samples | PCR- | Total | |
| COVID-19 IgG/IgM Rapid Test | IgG+ | 82 | 3 | 85 |
| IgG- | 1 | 224 | 225 | |
| Total | 83 | 227 | 310 | |
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