COVID-19 Molecular PCR Testing and Other Respiratory Pathogens
Updated March 22, 2022
In light of the outbreak of the novel 2019 Coronavirus, Madison Core Laboratories (MCL) has stepped up to assist in filling our community’s and Long-Term Care clients’ needs by offering Molecular Diagnostic Testing for SARS-CoV-2, the cause of the respiratory disease COVID-19, via order code M036.
CDC Guidance Docs | WHO Dashboard
Madison Core Labs is strictly following the guidelines set forth by the Center for Disease Control (CDC) strongly encouraging providers to test for other possible causes of respiratory illness and infections,
Different respiratory pathogens, including SAR-CoV-2, usually cause similar symptoms but demand distinct treatments. It is therefore essential to accurately recognize the infection agents of an illness. MCL offers a very diverse and effective Respiratory Pathogen Panel, the SARS-CoV-2 (COVID-19) Array Panel, to help accurately diagnose common respiratory infections, including COVID-19, with a quick turnaround time. This panel can identify 16 bacteria and viruses frequently seen in respiratory tract infections from a single patient specimen. We also offer a respiratory viral panel, M041, to detect influenza A/B and RSV in addition to SARS-CoV-2, from a single sample. SARS-CoV-2 only testing is available via order code M03.
How long does a PCR test take? Our technology delivers results in only a few hours. This reduces the time between testing and diagnosis so that patients and physicians can take appropriate steps sooner.
In late 2019, an emergence of a novel respiratory disease occurred in Wuhan, China. It was shortly thereafter discovered to be the Coronavirus Disease (COVID-19) caused by SARS-CoV-2. Since then, it has spread rapidly around the world and has been declared by the World Health Organization (WHO) as a pandemic on March 11, 2020. The WHO defines a pandemic as a global spread of a new disease. MCL has invested in the development of diagnostic testing to aid our community and the rest of the world in the fight against COVID-19.
Dr. Kairong Li
Technical Director, Molecular Diagnostics
Over the past year, Dr. Li and his team have been able to respond to significant surges in testing volumes while adapting to the presence of sub-variants in the population. All the while continuing to provide the highest quality testing available.
Symptoms Related to COVID-19
The Centers for Disease Control and Prevention (CDC) reports that symptoms may appear 2-14 days after exposure with various degrees of viral presentation. Reported illnesses have ranged from mild to severe disease and death for confirmed COVID-19 cases.
- Fever or chills
- Shortness of breath or difficulty breathing
- Muscle or body aches
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
*This list does not include all possible symptoms. CDC will continue to update this list as we learn more about COVID-19. Older adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness. The CDC updates this list on their website: Symptoms of Coronavirus
SARS-CoV-2 (COVID-19) Panel – Nasopharyngeal & Oropharyngeal Swabs
Our COVID-19 assay uses real-time polymerase chain reaction (RT-PCR) technology to detect the presence of SARS-CoV-2 in respiratory samples using a nasopharyngeal (NP) or Oropharyngeal (OP) swab. Clinicians are strongly encouraged by CDC to test for other causes of respiratory illness due to indistinguishable symptoms of most respiratory tract infections. The SARS-CoV-2 (COVID-19) Array Panel, offered by MCL, is a very diverse and effective Respiratory Pathogen Panel to diagnose common causes of respiratory illness, including COVID-19. In this Panel, the SARS-CoV-2 (COVID-19) test will be performed in combination with 15 other respiratory pathogen tests from a single patient specimen. Results are available within hours of testing. This panel provides efficient, fast, and accurate test results to help clinicians make critical decisions on appropriate patient management. The SARS-CoV-2 (COVID-19) Array Panel consists of the following pathogens:
- Haemophilus influenzae
- Klebsiella pneumoniae
- Legionella pneumophila
- Moraxella catarrhalis
- Mycoplasma pneumoniae
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Streptococcus agalactiae
- Streptococcus dysgalactiae
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Bordetella pertussis
- Respiratory Syncytial Virus Species (RSV)
- Influenza A
- Influenza B
- SARS-CoV-2 (COVID-19)
Section 3202(b) of the CARES Act requires that providers of diagnostic tests for COVID-19 publicly post the cash price for a COVID-19 diagnostic test on their website through the end of the public health emergency.
M036 SARS-CoV-2, NAA: $75.00 (Effective 06/01/2022)
COVID-19 Antibody Testing
Madison Core Labs currently offers the cobas Elecsys Anti-SARS-CoV-2 S antibody test.
Elecsys Anti-SARS-CoV-2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SAR-CoV-2 in human serum and plasma. The Elecsys Anti-SARS-CoV-2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti-SARS-CoV-2 S assay should not be used to diagnose or exclude acute SARS-CoV-2 infection.
Serologic methods have public health value for monitoring and responding to the COVID-19 pandemic, and clinical utility in providing care for patients.1
- Antibody testing does not replace virologic testing and should not be used to establish the presence or absence of acute SARS-CoV-2 infection.
- Antibody tests can vary in their individual performance characteristics; tests that have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) may be used for public health and clinical purposes.
- Antibody tests yielding qualitative, semi-quantitative, or quantitative results have been issued EUAs; there currently is no recognized public health or clinical indication for preferential use of semi-quantitative or quantitative tests.
- Virus-based neutralization assays are currently not authorized for emergency use by the FDA, although an enzyme-linked immunosorbent assay (ELISA)-based competitive neutralization test for qualitative detection of total neutralizing antibodies has been issued an EUA. Neutralization assays currently are being used as possible surrogates of protection in epidemiological and clinical studies.
- Antibody testing is not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination, to assess the need for vaccination in an unvaccinated person, or to determine the need to quarantine after close contact with someone who has COVID-19.
- Everyone should stay up to date on their vaccines (which include additional doses for immunocompromised individuals and booster doses at regular time points) and take steps to protect themselves and others from COVID-19, including people who have previously been infected and have detectable antibodies.
1. Interim Guidelines for Covid-19 Antibody Testing, Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html