Covid19 test in bulk

FDA Emergency Use Authorized

COVID-19
IgG/IgM Rapid Test Kit

(Covid19 test in bulk For Medical Professional Use Only, The test has EUA approval dated July 6. 2020 Submission number EUA200487  – Kit Includes 20 Tests and 3ml buffer)

As low as $9.99 in bulk
FREE SHIPPING on all orders

Covid19 test in bulk

Drugtestincup is starting wholesale of COVID19 test in bulk. We are offering the lowest price on the market, so you can get the COVID19 test as low as $14.25.

This kit will provide everything necessary for the detection of IgM and IgG antibodies to SARS-CoV-2 in human blood. Test will provide results in as little as 15 minutes!

The test we are offering is for professional use only and NPI number will be required when you order (someone will contact you before shipping or you can enter your number on checkout)

Important information

  • COVID-19 IgG/IgM Rapid Test Device is not for home use.
  • 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 for professional use only, medium to high complexity labs. Verification of Medical use will be needed upon purchase.
  • Authorized Laboratories: 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.
  • The test has EUA approval dated July 6. 2020 Submission number EUA200487
  • Health care professionals are responsible to meet all government guidelines, regulations, and rules to meet emergency use authorized regulations, CLIA waived, and all reporting requirements.

How does it work?

The COVID19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibody 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.

Covid-19 IgG/IgM Rapid Test Instructions for Use

Covid19 test in bulk

Test procedure

Allow the test device, specimen, buffer, and/or controls to reach room temperature 59F-86F (15-30°C) prior to testing.

  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. 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.
  3. Label the test with patient or control identification.
  4. 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.
  5. Wait for the blue line change to red line, read results at 15 minutes. Note: Specimens can also be applied using a micropipette.

Order now in bulk and save on your COVID test

NPI number required

Results interpretation

Clinical Evaluation:

For IgM detection:

MethodPCR+PCR-Total
COVID-19 IgG/IgM Rapid TestIgM+74276
IgM-5225230
Total79227306

For IgG detection:

MethodConvalescent samplesPCR-Total
COVID-19 IgG/IgM Rapid TestIgG+82385
IgG-1224225
Total83227310
Covid19 test in bulk

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.

Covid19 test in bulk

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:

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

Order now in bulk and save on your COVID test

NPI number required