2019 Novel Coronavirus Disease (COVID-19)

The 2019 novel Coronavirus disease (COVID-19) is a virus of global health significance caused by infection of severe acute respiratory syndrome coronavirus (SARS-CoV-2). COVID-19 is thought to spread from person to person in close contact through respiratory droplets.

Coronaviruses are a large family of viruses that are common in people and many different species of animals. COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it’s likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.)

Information About Laboratory Testing

Our priority at Sterling Pathology remains in the health and safety of our employees and to the healthcare providers and their patients we serve. COVID-19 testing is essential in helping corporations and healthcare providers to identify infected patients. We are working determinedly to develop and offer testing that will deliver quality and accurate results. Sterling Pathology is providing both COVID-19 Antibody and rt-PCR testing.

COVID-19 Isothermal nucleic acid PCR
The advantage of the iAMP COVID-19 Detection Kit is a real-time fluorescent reverse transcription isothermal assay intended for the qualitative detection of nucleic acid from the SARSCoV-2 in nasal, nasopharyngeal (NP), and oropharyngeal (OP) swabs from patients suspected of COVID-19 by their health care provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection.

COVID-19 EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG)
Sterling Pathology also offers an Anti-SARS-CoV-2 ELISA (IgG) antibody test to determine the presence of antibodies to SARS-CoV-2 (COVID-19, 2019 Novel Coronavirus) and can help to identify individuals who have already been exposed to the virus. We are running the FDA authorized for Emergency Use Authorization (EUA) assay EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG).

COVID-19 Testing at Sterling Pathology

The iAMP COVID-19 Detection Kit is a real-time reverse transcription isothermal amplification test. The test is based on a proprietary isothermal amplification technology termed OMEGA amplification (Patent: WO 2017/205510 A1; publication: The Journal of Molecular Diagnostics, Vol.22, No 3, 419-428, 2020). OMEGA primer sets are designed to specifically detect RNA and later cDNA from the nucleocapsid (N) and ORF-1ab genes of the SARSCoV-2 virus in nasal, nasopharyngeal and/or oropharyngeal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. The iAMP COVID-19 assay's key differentiator from current rRT-PCR COVID-19 assays is its ability to detect SARS-CoV-2 RNA directly from samples without prior RNA extraction process.

Our assay is testing for IgG antibodies produced in response to an exposure to COVID 19. The EUROIMMUN Anti-SARS-CoV-2 ELISA is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole bases for patient management decisions. Results must be combined with clinical observations, patient history, and epidemiological information. This test helps to differentiate between an acute infection and someone who was infected and now is producing antibodies for the for the seeable future. It's being used to screen employees for the presence of antibody to better determine suitability to return to work, and is FDA approved as an Emergency Use Assay (EUA).

Knowing if someone has developed antibodies and a potential immune response to coronavirus can be helpful in determining if workers are able to return to work or continue healthcare workers are able to continue to care for patients.  Dr. Changgao Yang, our Chief Medical Officer and President of Sterling Pathology believes that “the test will play a critical role in helping alleviate anxiety about their exposure to coronavirus”.

For the most up to date information on COVID-19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage: https://www.cdc.gov/COVID-19

If you are a corporation or healthcare provider seeking additional information about COVID-19 testing please contact
Sterling Pathology at 1-800-899-8480 for details on how to order the tests
.


Where can I go for updates and more information?
CDC webpages:
General: https://www.cdc.gov/COVID19
Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html
FDA webpages:
General: www.fda.gov/novelcoronavirus
EUAs: (includes links to patient fact sheet and manufacturer’s instructions)
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
https://www.fda.gov/media/137608/download
https://www.fda.gov/media/137607/download
https://www.fda.gov/media/137609/download
Sterling Pathology National Laboratories:
Sterling Pathology
3030 Old Ranch Parkway, Suite 430
Seal Beach, CA 90740

Website: http://www.sterlingpath.com
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Customer Service: 1(800)899-8480COVID-19
Updates Page: http://sterlingpath.com/index.php/covid-19
 

Click here  to download the COVID-19 patient resource for diagnostic testing.

Click here  to download the COVID-19 fact sheet for recipients.

Click here  to download the PCR physician resource.

Click here  to download fact sheet for healthcare providers

Click here  to download Anti-SARS-CoV-2 ELISA (IgG) - Instruction for use


Test Request Documents:

Click here  to download Requisition

Click here  to download Consent Form

Click here  to download Privacy Notice



Click here  to access the FAQ’s