Result Interpretation

IgM(-) & IgG(-): Negative

1. IgM(+) & IgG(-): Positive; Indication of an acute infection

2. IgM(+) & IgG(+): Positive; Indication of an ongoing infection

3. IgM(-) & IgG(+): Positive; Indication of a past infection

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

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

  1. Target Region: ORF1ab and N-genes

  2. Internal Control (IC) : Genes of RNaseP

  3. Assay Runtime: 72 minutes

  4. Clinical Sensitivity: 94.9%

  5. Clinical Specificity: 98.7%

  6. Precision: CV<5%

  7. Sample Input Volume: 5 μL

  8. 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

  1. RT-PCR Buffer

  2. Reaction Mix

  3. Positive Control

  4. 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

COVID-19 Coronavirus Real Time PCR Kit Performance Data*

Limit of detection (LoD)

Fifteen SARS-CoV-2 positive clinical specimens that included equal numbers of nasopharyngeal swabs, throat swabs and sputum, were serially diluted to various concentrations. Quantitative RT-PCR was used to estimate the concentration of virus in each specimen prior to dilution Each specimen dilution was tested 20 times and the level at which ≥95% of results were positive was used to estimate the limit of detection (LoD). Three lots of COVID-19 Coronavirus Real Time PCR Kits were included in the study. For each specimen type, the LoD was estimated to be 3.5×102copies/mL

To confirm the LoD, 15 other clinical specimens that included nasopharyngeal swabs, throat swabs and sputum, were gradient diluted. Three lots of Real-time PCR reagents were used to test each diluted specimen 20 times.

For each specimen type, ≥95% of results were reported as positive with each lot of reagents and the LoD was therefore confirmed as 3.5×102copies/mL. Further confirmation on of LoD was done using alternative PCR Instrument Systems such as ABI 7500, QuantStudio™ 5 and Roche LightCycler® 480 Real-time PCR instruments.

Cross Reactivity

In silico exclusivity analysis was conducted to examine the possible cross-reactions between all the organisms (listed below) and the COVID-19 Coronavirus Real Time PCR Kit primers and probes. SARS-CoV (including bat-like SARS coronavirus) is the only organism identified as potentially cross-reactive by in silico analysis.

Based only on sequence analysis, the possibility that the COVID-19 Coronavirus Real Time PCR Kit may cross-react with SARS-CoV cannot be ruled out. However, SARS-CoV has not been detected in the human population since 2004. In addition, the COVID-19 Coronavirus Real Time PCR Kit was challenged with nucleic acids isolated from SARS-CoV and other human coronaviruses to confirm that the kit did not cross-react.

• Human coronavirus 229E

• Human coronavirus OC43

• Human coronavirus HKU1

• Human coronavirus NL63

• SARS-coronavirus

• MERS-coronavirus

• Adenovirus (Ad. 71)

• Human Metapneumovirus (hMPV)

• Parainfluenza virus 1

• Parainfluenza virus 2

• Parainfluenza virus 3

• Influenza A (H1N1)

• Influenza A (H3N2)

• Influenza B

• Enterovirus Type 71

• Respiratory syncytial virus

• Rhinovirus

• Chlamydia pneumoniae

• Haemophilus influenzae

• Legionella pneumophila

• Mycobacterium tuberculosis

• Streptococcus pneumoniae

• Streptococcus pyogenes

• Bordetella pertussis

• Mycoplasma pneumoniae

• Pooled human nasal wash – to represent diverse microbial flora in the human respiratory tract

• Candida albicans

• Pseudomonas aeruginosa

• Staphylococcus epidermis

• Staphylococcus salivarius

Interfering Substances

The potential for interference with the COVID-19 Coronavirus Real Time PCR Kit by substances that may be found in respiratory specimens was evaluated by testing each substance listed below in SARS-CoV-2 positive and negative sputum. Results showed that the substances below did not interfere with the detection of negative and weak positive specimens by the COVID-19 Coronavirus Real Time PCR Kit.

• Fresh blood

• Nasal secretions

• Mucus

• Mucin

• Phenylephrine

• Oxymetazoline

• Sodium chloride

• Perchloromethasone

• Dexamethasone

• Flunisolide

• Triamcinolone acetonide

• Budesonide

• Mometasone

• Fluticasone

Agreement between the Bioperfectus COVID-19 Real Time PCR kit and clinical diagnosis

*Additional data can be found in the IFU.

Documents

• IFU COVID-19 Coronavirus Real Time PCR Kit

• Fact Sheet HCP

• Fact Sheet Patients

• COVID-19 Coronavirus Real Time PCR Kit Brochure

• Emergency Use Authorization Letter

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:

• Antibody tests are 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 in 15 minutes.

• RT-PCR test are conducted by a healthcare professional, using a long swab to collect a sample of DNA, for example, 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 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.