Diazyme DZ-Lite SARS CoV-2 IgM and IgG CLIA Kits Frequently Asked Questions (FAQs)

NOTICE: Diazyme does not perform the COVID-19 antibody test but makes it. The serological test is for prescription use only to be conducted by a healthcare professional in a clinical lab setting. Please seek advice from your own healthcare provider on which type of testing is appropriate in your unique situation.

  1. About Diazyme Laboratories, Inc.
  2. What is SARS-CoV-2 and What is COVID-19?
  3. What is the Incubation Period for COVID-19?
  4. What are the Guidelines on Testing People for COVID-19?
  5. What is IgM and What is IgG?
  6. What are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  7. How Are the Diazyme Kits Useful?
  8. How Are the Diazyme Kits Different from RT-qPCR?
  9. How Do the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Work?
  10. Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Microplate-Based?
  11. Do I need a Special Analyzer to Run the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  12. What are the Dimensions of the Diazyme DZ-Lite 3000 Plus Analyzer?
  13. Does the Diazyme DZ-Lite 3000 Plus Analyzer Need Special Water/Waste Hookups?
  14. What is the Throughput of the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  15. How Many Tests are there in the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  16. What Type of Samples Can I Use with the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  17. How do I Ship Specimen to Be Tested with the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  18. What are the Storage Conditions and Stability Profiles for the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  19. What is the Cut-Off for Reporting Results?
  20. Can I Test Pooled Samples?
  21. What are the Interference and Cross-reaction Profiles of the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  22. Do the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Include Calibrators and Controls?
  23. How Sensitive Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  24. How Specific Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  25. Why are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Important during the Current Pandemic?
  26. What are the Cross-reactivity Profiles of the Diazyme SARS-CoV-2 IgM and IgG CLIA Kits?
  27. Which SARS-CoV-2 Antigen is Used in the Diazyme IgM/IgG CLIA Kits?
  28. Regulatory Statements


  1. About Diazyme Laboratories, Inc.
    Diazyme Laboratories, Inc. (Diazyme) is a cGMP and ISO 13485 certified medical device manufacturer located in Poway, California. The company is an affiliate of San Diego-based General Atomics and has been in business for 20 years. With subsidiaries in Germany and in China and over 150 employees, Diazyme develops user-friendly and high-throughput diagnostic reagents which can be used on automated chemistry analyzers. Diazyme's line of products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, electrolytes and infectious diseases.
     
  2. What is SARS-CoV-2 and What is COVID-19?
    Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the official name of the novel coronavirus that is currently causing a worldwide pandemic. COVID-19 is the official name of the respiratory disease caused by SARS-CoV-2. SARS-CoV-2 is highly contagious and is transmitted through respiratory droplets and contact with contaminated surfaces. More information about COVID-19 can be found at the Center for Disease Control and Prevention CDC website: https://www.cdc.gov/coronavirus/2019-nCoV/index.html as well as on https://www.coronavirus.gov/ 

  3. What is the Incubation Period for COVID-19?
    Although several studies are still in progress, according to the March 10th, 2020 study published in the Annals of Internal Medicine, the incubation period for COVID-19 as measured from publicly confirmed cases is as follows1

1Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 Mar 10.

  1. What are the Guidelines on Testing People for COVID-19?
    The CDC is continuously updating this information at: https://emergency.cdc.gov/han/2020/han00429.asp

    As of March 08, 2020, the CDC stated that “Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested”. In addition, priority testing should be given to:

    1. Hospitalized patients who have signs and symptoms compatible with COVID-19 in order to inform decisions related to infection control.
    2. Other symptomatic individuals such as, older adults (age ≥ 65 years) and individuals with chronic medical conditions and/or an immunocompromised state that may put them at higher risk for poor outcomes (e.g., diabetes, heart disease, receiving immunosuppressive medications, chronic lung disease, chronic kidney disease).
    3. Any persons including healthcare personnel, who within 14 days of symptom onset had close contact with a suspect or laboratory-confirmed COVID-19
      patient, or who have a history of travel from affected geographic areas within 14 days of their symptom onset.

  2. What is an IgM and What is an IgG?
    Upon infection with the SARS-CoV-2 virus, the patient’s immune system tries to fight the virus by producing blood-circulating molecules known as antibodies. IgM is a class of antibodies that appears early after an infection (as early as 3-5 days). IgM is the body’s first line of defense against a foreign antigen. IgG is another class of antibodies that appears later and gradually replaces the IgM antibodies. Usually, IgG antibodies appear in the blood circulation within 3-4 weeks after initial infection. The presence of SARS-CoV-2-specific IgM and/or IgG antibodies in the blood of a patient is a strong indication that the patient has been infected with the SARS-CoV-2 virus.
     
  3. What are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
  1. How Are the Diazyme Kits Useful?
  1. How Are the Diazyme Kits Different from RT-qPCR?
    The current nucleic acid test for SARS-CoV-2 is based on the detection of the virus’ ribonucleic acid (RNA) using a modified version of the polymerase chain reaction technique (RT-qPCR). Although the test is sensitive, it suffers from several limitations that include: 

The new SARS-CoV-2 IgM CLIA and SARS-CoV-2 IgG CLIA tests have/are:

  1. How Do the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Work?
  1. Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Microplate-Based?
    No, the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA tests do not use microplates and are not ELISA assays. Samples are loaded in batch on the chemiluminescence analyzer in a manner similar to that of a general chemistry analyzer.

  2. Do I need a Special Analyzer to Run the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Yes, the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA tests are closed barcoded systems that run only on the Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer, which is provided by Diazyme to prospective clinical labs. The Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer is an FDA 510k cleared instrument for clinical diagnostic uses.

  3. What are the Dimensions of the Diazyme DZ-Lite 3000 Plus Analyzer?

Please contact our Technical Support at support@diazyme.com for analyzer installation requirements.

  1. Does the Diazyme DZ-Lite 3000 Plus Chemiluminescence Analyzer Need Special Water/Waste Hookups?
    No, the Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer is a self-contained water/waste system and does not need to be connected to lab water/waste hookups.

    Please contact our Technical Support at support@diazyme.com for analyzer installation requirements.

  2. What is the Throughput of the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    When running both the IgM and IgG tests in parallel, the throughput on the Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer is estimated at ~ 50 tests/hour.

  3. How Many Tests are there in the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Both the DiazymeDZ-Lite SARS-CoV-2 IgM and IgG CLIA kits contain 100 tests each.

  4. What Type of Samples Can I Use with the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?

Please refer to the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19): https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html as well as your local, state and federal government’s mandated requirements.

  1. How do I Ship Specimen to Be Tested with the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits to Clinical Laboratories?
    It is recommended to ship samples at 2-8°C using an overnight freight service. Alternatively, samples can be shipped frozen. Before shipping, it is recommended that specimens be removed from the separator, red blood cells or clot. Heat inactivation should be performed prior to removing from the separator, red blood cells or clot.

  2. What are the Storage Conditions and Stability Profiles for the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Store all kit components at 2-8°C. 
  1. What is the Cut-Off for Reporting Results?
    The recommended Cut-Off for both the Diazyme IgM and IgG CLIA kits is 1.00 AU/mL: Results strictly lower than 1.00 AU/mL are reported “Negative”. Results higher than 1.00 AU/mL are reported “Positive”. Patients having results near the Cut-Off should have follow-up tests. Because, results may differ between laboratories due to variations in population. It is recommended that each laboratory establish its own expected cut-off.

  2. Can I Test Pooled Samples?
    No

  3. What are the Interference and Cross-reaction Profiles of the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Please refer to the package insert.

  4. Do the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Include Calibrators and Controls?
    Yes, the kits include two calibrators (one high and one low) and two controls: one
    positive and one negative.

  5. How Sensitive Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Clinical sensitivity is defined as the ability to correctly identify those patients who were infected. 
  1. How Specific Are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits?
    Clinical specificity is defined as the ability to correctly identify those patients who were not infected. 
  1. Why are the Diazyme DZ-Lite SARS-CoV-2 IgM and IgG CLIA Kits Important during the Current Pandemic?
    Controlling the spread of the SARS-CoV-2 virus relies heavily on the fast and accurate identification of the infected persons and their isolation from the general population. With the exponentially increasing number of people showing COVID-19 symptoms, large-scale testing of symptomatic populations is now inevitable. With its high-throughput and low complexity, the Diazyme DZ-Lite SARS-CoV-2 CLIA IgM/IgG tests are suitable for large scale roll out of SARS-CoV-2 testing and can adequately complement the RT-qPCR tests results in patients with active infections. Additionally, the new tests can help identify patients who were infected early on and who have since recovered.

    In conjunction with other tests, the Diazyme DZ-Lite SARS-CoV-2 CLIA IgM/IgG tests can help decision makers at the local, state and federal levels take the appropriate confinement measure to slow the progression of the SARS-CoV-2 outbreak.
  1. What are the Cross-reactivity Profiles of the Diazyme SARS-CoV-2 IgM and IgG CLIA Kits?
    The cross-reactivity of both Diazyme SARS-CoV-2 IgM and IgG CLIA kits to antibodies against various viruses (including four coronaviruses) and bacteria has been tested. Results are shown below:

    Cross-Reactant

    Cross-Reactivity Result 

    Influenza A virus antibodies

    Negative

    Influenza B virus antibodies

    Negative

    Parainfluenza virus antibodies

    Negative

    Respiratory syncytial virus antibodies

    Negative

    Adenovirus antibodies

    Negative

    EBV NA IgG

    Negative

    EBV VCA IgG

    Negative

    EBV VCA IgM

    Negative

    Measles virus antibodies

    Negative

    CMV IgG

    Negative

    CMV IgM

    Negative

    Varicella zoster virus antibodies

    Negative

    M.Pneumonia IgG

    Negative

    M.Pneumonia IgM

    Negative

    Chlamydia pneumoniae IgG

    Negative

    Chlamydia pneumoniae IgM

    Negative

    Antinuclear antibodies (ANA)

    Negative

    Candida albicans

    Negative

    Human coronavirus HKU1(HCoV-HKU1)

    Negative

    Human coronavirus OC43(HCoV- OC43)

    Negative

    Human coronavirus NL63(HCoV-NL63)

    Negative

    Human coronavirus 229E(HCoV-229E)

    Negative


     Additionally, the Diazyme SARS-CoV-2 IgM CLIA kit did not cross-react with SARS-CoV-2 IgG antibodies and vice versa (the Diazyme SARS-CoV-2 IgG CLIA kit did not cross-react with SARS-CoV-2 IgM antibodies).


  2. Which SARS-CoV-2 Antigen is Used in the Diazyme IgM/IgG CLIA Kits?
    For optimum specificity, the Diazyme SARS-CoV-2 IgM and IgG CLIA kits specifically use the N and S proteins of the virus as antigens for the IgM and IgG antibodies.


  3. Regulatory Statements  
    According to the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on March 16, 2020, the information listed below applies to both the Diazyme DZ-Lite SARS-CoV-2 CLIA IgM and the Diazyme DZ-Lite SARS-CoV-2 CLIA IgG kits: 

 

Diazyme’s DZ-Lite SARS-CoV-2 CLIA IgM and IgG FDA notifications are now listed on the FDA’s website under “FAQs on Diagnostic Testing for SARS-CoV-2”: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

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