Fast Step, 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.
Included in Covid19 test kit:
- Individually Packed Test Device
- Disposable Pipettes
- Buffer
- Package Insert
Covid19 rapid test 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 IgG/IgM 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.
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 |
Covid-19 IgG/IgM Rapid Test Instructions for Use
Test procedure
Allow the 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.
Results interpretation
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 | |
IgM Positive:*The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgM test region. The result is positive for COVID-19 virus specific-IgM antibodies.
IgG Positive:*The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgG test region. The result is positive for COVID-19 virus specific-IgG antibodies.
IgM and IgG Positive:*The colored line in the control region (C) changes from blue to red, and two colored lines should appear in IgG and IgM test regions. The color intensities of the lines do not have to match. The result is positive for IgM and IgG antibodies.
Negative: The colored line in the control region (C) changes from blue to red. No line appears in IgM or IgG test regions.
Invalid: Control line (C) is still completely or partially blue, and fails to completely change from blue to red. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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, 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)
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