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COVID-19 Testing and Service Options

We’re currently working to provide a complete suite of COVID-19 diagnostic tests and services.

Request a Quote for COVID-19 Test Kits

COVID-19 Testing Options

ThermoGenesis will offer a comprehensive line of coronavirus testing products. From RT-PCR and antigen test products to Emergency Use Authorized ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit, we are a one-stop shop solution for CLIA-certified laboratories.

 

 

IgM/IgG Antibody Tests are lateral flow kits that can indicate recent or prior infection

 

 

 

Antigen tests are immunoassays that detect the presence of a specific viral antigen

 

 

 

RT- PCR tests are used to directly detect the presence of viral RNA

Antibody Test

The ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate).

The ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Testing 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.

Antibody Test Kit Features:

    • Uses 10uL of sample volume
    • Dual differential detection of IgG and IgM antibodies of SARS-CoV-2
    • Results seen in 15 minutes
    • Visual interpretation of results, including an internal control
    • No special additional equipment needed
    • Room temperature storage or refrigeration (2-30⁰C / 35.6-86⁰F)

 

Test Principle

The ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N-protein antigen and mouse anti human IgM/IgG antibody. SARS-CoV-2 IgM/IgG in the sample reacts with SARS-CoV-2 recombinant N-protein antigen bound to gold particles. This complex migrates along the membrane and reaches the IgM/IgG test line (T) which contains mouse anti human IgM/IgG antibody against SARS-CoV-2 IgM/IgG complex. The sample diluent is supplied for the lateral chromatography process, to provide a suitable environment for the reaction of antigen and antibody.

The antibody test kit comes with the following:

    • Instructions for Use
    • Test Cards
    • Sample Diluent (Phosphate buffer containing casein)
    • Dropper

Coronavirus Test Procedure

Result Interpretation

 

 

 

 

 

 

 

 

  1. IgM(-) & IgG(-): Negative
  2. IgM(+) & IgG(-): Positive; Indication of an acute infection
  3. IgM(+) & IgG(+): Positive; Indication of an ongoing infection
  4. IgM(-) & IgG(+): Positive; Indication of a past infection

 

ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit Clinical Data

 

SARS-CoV-2 IgM/IgG Antibody Test Kit Sensitivity

 

SARS-CoV-2 IgM/IgG Antibody Test Kit Specificity

 

SARS-CoV-2 IgM/IgG Antibody Test Kit Different Stages

Sample Source: Samples were collected from 197 serum samples of 40 patients with COVID-19 on 1-7 days, 8-14 days, and at least 15 days after the onset of the disease to evaluate the coincidence rate of IgM / IgG over time.

Documents

 

Learn more about our COVID-19 Antibody Test Kit or inquire about testing services, please contact us at sales@thermogenesis.com.

Antigen Test

The COVID-19 Antigen Test Kit is an enzyme-linked immunosorbent assay intended for the detection of nucleocapsid protein (N protein) antigen from SARS-CoV-2 in human serum from individuals who are suspected of COVID-19 by their healthcare provider.

The COVID-19 Antigen Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in techniques of in vitro diagnostic procedures and tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Antigen Test Kit Information

    • Identification: SARS-CoV-2 N protein antigen.
    • Size: 1×96 wells
    • Sensitivity: Cut-off control
    • Incubation Time: 1 Hour, 45 minutes
    • Sample Type: Serum
    • Species Sample: Human
    • Sample Size: 50 µL
    • Storage: stored at 2°C-8°C

 

To learn more about our COVID-19 Antigen Test Kit or inquire about testing services, please contact us at sales@thermogenesis.com.

RT-PCR Test

The COVID-19 Coronavirus Real Time PCR Kit is a real-time fluorescent RT-PCR based assay intended for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum from individuals who are suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

RT-PCR Test Kit Features:

    • Technology: Multiplex real-time PCR
    • Target Region: ORF1ab and N-genes
    • Internal Control (IC) : Genes of RNaseP
    • Assay Runtime: 72 minutes
    • Clinical Sensitivity: 94.9%
    • Clinical Specificity: 98.7%
    • Precision: CV<5%
    • Sample Input Volume: 5 μL
    • Storage Temperature: -20°C ± 5°C

 

Test Principle

RNA isolated and purified from upper and lower respiratory tract specimens is reverse transcribed to cDNA and amplified in a Real-time PCR instrument using one-step Master Mix. Probes consist of a reporter dye at the 5’ end and quenching dye at the 3’ end. The fluorescent signals emitted from the reporter dye are absorbed by the quencher. During PCR amplification, probes hybridized to amplified templates are degraded by the Taq DNA polymerase with 5’-3’ exonuclease activity, thereby separating the reporter dye and quencher and generating fluorescent signals that increase with each cycle. The PCR instrument automatically draws a real-time amplification curve for each optical channel based on the signal change, and calculates cycle threshold (Ct) values (the point at which fluorescence is detectable above background) that are interpreted by the operator to determine the presence/absence of SARS-CoV-2 RNA.

The RT-PCR test kit comes with the following:

    • RT-PCR Enzyme Mix
    • RT-PCR Buffer
    • Reaction Mix
    • Positive Control
    • Blank Control

 

Instruction for Use

Step 1: Collect a sample with an upper respiratory swab
Step 2: Extract the nucleic acid automatically with instrument
Step 3: Mix the reaction system and add the nucleic acid sample
Step 4: Run the real-time PCR program
Step 5: Get the result

 

Documents

 

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories;

Learn more about the COVID-19 Coronavirus Real Time PCR Kit or inquire about testing services, please contact us at sales@thermogenesis.com.

COVID-19 FAQs

Answering your Coronavirus Testing Questions

Who Should Get Tested?

People who have symptoms of COVID-19, have had close contact with someone with confirmed COVID-19 or have been asked or referred to get testing by their healthcare provider or state health department.

How it Works

Each test works differently:

  • The antibody test is conducted by a healthcare professional, using a small blood sample. The sample is mixed in with a diluent, placed on a test card and results are available within 15 minutes.
  • The antigen test is conducted by a healthcare professional, using a small volume of serum. The sample is then sent off for analysis.
  • The PCR test is conducted by a healthcare professional, using a long swab to collect a sample of DNA from the back of an individual’s nose and throat. The sample is then sent off for analysis.

What’s Measured?

Each test measures different things:

  • The antibody test detects if an individual has developed the IgM/IgG antibodies necessary to combat a COVID-19 infection, indicating that they have been previously exposed to the virus.
  • The antigen test detects specific proteins on the surface of the virus.
  • The PCR test indicates whether there is an active viral infection present in an individual’s sample

Why Choose Us?

For more than two decades, ThermoGenesis has been developing innovative medical devices and providing researchers around the world with trusted and effective tools needed to get the job done.

How you can help slow the spread

  • Practice social distancing by staying six feet away from everyone not in your immediate household
  • Cover your face when going outside or to public areas
  • Wash your hands frequently
  • If you get tested, self-quarantine/isolate at home pending test results and follow the advice of your health care provider or a public health professional.


COVID-19 General FAQs

1.  What is a novel coronavirus?

A novel coronavirus is a new coronavirus that has not been previously identified. The virus causing coronavirus disease 2019 (COVID-19) is not the same as the coronaviruses that commonly circulate among humans and cause mild illness, like the common cold.

2. What is a coronavirus disease 2019 (COVID-19)?

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. There are many types of human coronaviruses, including some that commonly cause mild upper-respiratory tract illnesses. COVID-19 is a new disease, caused by a novel (or new) coronavirus that has not previously been seen in humans. Current symptoms reported for patients with COVID-19 have included mild to severe respiratory illness with fever, cough, and difficulty breathing.

3. How can I prevent COVID-19?

The best way to prevent illness is to avoid being exposed to the virus. CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases.

4. What treatments are available for COVID-19?

People with COVID-19 should receive supportive care to help relieve symptoms. People with mild symptoms are able to recover at home. If you experience a medical emergency such as trouble breathing, call 911 and let the operator know you may have COVID-19. For severe illness, treatment should include care to support vital organ functions.

Currently there are no FDA-approved drugs specifically for the treatment of COVID-19. Researchers are studying new drugs, and drugs that are already approved for other health conditions, as possible treatments for COVID-19. The FDA is working with drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments. CDC has more information for health care providers about these potential treatments. Never take a prescription medicine or drug if it is not prescribed for you by your doctor for your health condition.

Additional information and updates on COVID-19:

Centers for Disease Control and Prevention

National Institutes of Health

World Health Organization — International Summary

Food and Drug Administration — Coronavirus Disease 2019 (COVID-19) FAQs

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