Covid-19
IgG/IgM Rapid Test

(Professional use only, EUA Authorize - Kit Includes 20 Tests and 3ml buffer)

As low as $14.95 in bulk

FREE SHIPPING on all orders

NPI number required

Test Results Can Be Read in as Little as 15 Minutes!

FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit

An Easy to Use Antibody Test

12 Panel Now is pleased to provide a COVID-19 (Coronavirus) Rapid Test Device. This test kit includes everything necessary for the detection of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood. This test kit will provide results in as little as 15 minutes!

What is a COVID-19 IgG/IgM Rapid Test?

This is a blood test that detects immune proteins (antibodies) within the body.  By detecting these antibodies, it will determine whether the body has been exposed to the COVID-19 Coronavirus (SARS-CoV-2).

What Does the COVID-19 IgG/IgM Rapid Test Device Detect?

The COVID-19 IgG/IgM Rapid 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.

Who Can Purchase the COVID-19 IgG/IgM Rapid Test Device?

  • This test is for professional use only. 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.
  • HEALTH CARE PROFESSIONALS ARE RESPONSIBLE TO MEET ALL GOVERNMENT GUIDELINES, REGULATIONS AND RULES TO MEET EMERGENCY USE AUTHORISED REGULATIONS, CLIA WAIVED AND ALL REPORTING REQUIREMENTS
  • An NPI number will be requested and verified upon purchase.

Included Materials:

  • Individually Packed Test Device
  • Disposable Pipettes
  • Buffer
  • Package Insert

Product Information:

  • The test has EUA approval dated July 6. 2020 Submission number EUA200487
  • FDA Emergency Use Authorization (EUA)
  • Rapid results within 15 minute
  • Sold in packs of 20
  • Shelf life of up to 24 months from manufacture date
  • Verification of medical use before shipping is mandatory

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:

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

www.cdc.gov/csels/dls/locs

Covid-19 IgG/IgM Rapid Test Instructions for Use

  1. 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.
  2. Place the test device on a clean and level surface.
  3. (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.
  4. 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).
  5. 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.

NPI number required

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

Results interpretation:

gM-Positive

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

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

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

Negative: The colored line in the control region (C) changes from blue to red. No line appears in IgM or IgG test regions.

nvalid

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.

Antibody Test for IgG

This test detects IgG antibodies that develop in most patients within seven to 10 days after symptoms of COVID-19 begin. IgG antibodies remain in the blood after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past and have developed antibodies that may protect you from future infections. It is unknown at this point how much protection antibodies might provide against reinfection.

Antibody Test for IgM

This test detects IgM antibodies. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus. When IgM is detected you may still be infected, or you may have recently recovered from a COVID-19 infection.

FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
Test Results Can Be Read in as Little as 15 Minutes!

NPI number required

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 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 humans1. 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 COVID-19 IgG/IgM Rapid Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody. It will provide a presumptive diagnosis of COVID-19. 

Letter to Healthcare Providers 

FAQ

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 humans1. 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 COVID-19 IgG/IgM Rapid Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody. It will provide a presumptive diagnosis of COVID-19

The COVID-19 IgG/IgM Rapid Test Device should be stored at 35 – 86 degrees Fahrenheit when not in use.

The device should never be frozen. If refrigerated, allow the buffer, specimen, and device to reach room temperature before use. The advised storage is 2-30⁰C / 36-86⁰F.

It is important not to leave specimens at room temperature for prolonged periods.  Serum and plasma specimens may be stores at 35-46 degrees F for up to seven days.  Do not freeze whole blood specimens.

12 Panel Now’s COVID-19 IgG/IgM Rapid Test Device is not for home use.  The use of this particular rapid test is limited to Health Care institutions and Medical Distribution Companies certified to perform high complexity testing.

This test has not been reviewed by the FDA. This test has been authorized only for the presence of IgM and IgG antibodies against SARSCoV-2, not for any other viruses or pathogens.

Check Out the Latest from Our Blog!

FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
Test Results Can Be Read in as Little as 15 Minutes!

NPI number required