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COVID-19 | SARS-CoV-2

Information and Testing Options

Diagnostic Solutions Laboratory offers three testing options for COVID-19 | SARS-CoV-2.

 
 

1COVID-19 Diagnostic Test

Oral and Nasopharyngeal (NP)

COVID-19 NP Collection

Testing done to identify COVID-19 uses real-time polymerase chain reaction (RT-PCR) technology to detect the presence of SARS-CoV-2 in respiratory samples.

Our COVID-19 Assay is listed on the FDA website as authorized under Emergency Use Authorization (EUA) guidelines.

Authorization Documents: HCP | Patients | EUA Summary

 

2COVID-19 IgG/IgM Antibody Test

Blood and Plasma

COVID-19 IgG/IgM Antibody Test

The COVID-19 Antibody Test* is a simple blood test that uses superior ELISA technology to detect the qualitative presence of the human Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies that bind to the SARS-CoV-2 virus (the novel virus that causes COVID-19). The test can be used in both symptomatic and asymptomatic patients – making it a useful tool in identifying patients who have been exposed to COVID-19.

The COVID-19 IgG/IgM Antibody Test is a critical tool in helping practitioners understand the trajectory of the SARS-CoV-2 virus and its spread.

IgG/IgM Antibody Test Orders

IMPORTANT: The COVID-19 IgG/IgM Antibody Test Must Be Ordered by Phone (877) 485-5336. COVID-19 IgG/IgM Antibody Testing is not currently available via our online portal.

Services provided are for laboratory testing only. No charge is incurred for ordering collection kits.

The Role of IgG and IgM Antibody Testing in COVID-19

IgG and IgM antibodies indicate two different stages of the immune response to the COVID-19 virus. Understanding the IgG/IgM response to SARS-CoV-2 can help practitioners identify patient exposure to SARS-CoV-2.

IgG and IgM antibodies both play key roles in the progression and management of COVID-19.

  • IgM antibodies are typically detected earlier in the course of an infection than IgG antibodies. Studies published to date indicate that IgM antibodies to SARS-CoV-2 are usually detected within the first week after symptom onset, peak within 3 to 4 weeks, and then begin to decline.3
  • IgG antibodies to SARS-CoV-2 are often detected after the first week of symptom onset. Although the longer-term trends for IgG antibodies in COVID-19 have not yet been established, previous studies in SARS indicated that IgG antibodies peaked within a few months after symptom onset, and gradually declined thereafter.3

Novel Coronavirus COVID-19 IgG and IgM ELISA Tests Performed by Diagnostic Solutions Laboratory

Read Technical Information

Why Choose Diagnostic Solutions' COVID-19 IgG/IgM Antibody Test?

  • DSL's IgG/IgM test uses an FDA-validated kit which has been designated for In Vitro Diagnostics (IVD) use.
  • Testing components are of the highest quality and are manufactured exclusively in the US.
  • Our test requires a simple blood draw, which is more reliable than a rapid blood spot or finger prick blood test, which may not contain enough blood to perform adequately.
  • Our assay demonstrated 100% analytical sensitivity and specificity in a study of 84 cohorts.

The Following Individuals Can Benefit from the COVID-19 Antibody Test:

  • Patients with confirmed diagnosis of COVID-19
  • Patients with suspected, but unconfirmed diagnosis of COVID-19*
  • Asymptomatic patients who may have had a previous exposure to the SARS-CoV-2 virus

 


* NOTE:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

 

3SARS-CoV-2 Stool Analysis

Coronavirus Stool Test/Screening and Surveillance

SARS-CoV-2 Stool Test

The SARS-CoV-2 stool test also uses RT-PCR technology to detect the presence of SARS-CoV-2 in stool.

SARS-CoV-2 Stool Test Orders

IMPORTANT: SARS-CoV-2 Stool Analysis Must Be Ordered by Phone (877) 485-5336. SARS-CoV-2 Stool testing is not currently available via our online portal. DO NOT use the GI-MAP kit for SARS-CoV-2 testing, it IS NOT the same test.

 Not approved or evaluated by the FDA. This test is for investigational or Research Use Only (RUO).
Services provided are for laboratory testing only. No charge is incurred for ordering collection kits.


Research from around the world indicates that as many as 50 percent of patients who are positive for SARS-CoV-2 experience gastrointestinal complaints.1

Furthermore, evidence suggests SARS-CoV-2 is detectable in stool and its presence in stool may last for up to five weeks after clearance from the respiratory tract. A recent article published in Lancet states:

"Our data suggest the possibility of extended duration of viral shedding in faeces, for nearly 5 weeks after the patients' respiratory samples tested negative for SARS-CoV-2 RNA. Although knowledge about the viability of SARS-CoV-2 is limited, the virus could remain viable in the environment for days, which could lead to faecal-oral transmission, as seen with severe acute respiratory virus CoV and Middle East respiratory syndrome CoV. Therefore, routine stool sample testing with real-time RT-PCR is highly recommended after the clearance of viral RNA in a patient's respiratory samples. Strict precautions to prevent transmission should be taken for patients who are in hospital or self-quarantined if their faecal samples test positive."2

Please read our technical article, "Coronavirus Stool Testing with the SARS-CoV-2 qPCR Stool Test from Diagnostic Solutions Laboratory."**

** The SARS-CoV-2 Stool Analysis is not diagnostic of COVID-19. COVID-19 disease can only be diagnosed with positive SARS-CoV-2 results on a respiratory sample.

 

 

 
 

Summary

COVID-19 is an infectious disease the World Health Organization has identified as a global pandemic. SARS-CoV-2 is a novel, single strand RNA virus that causes COVID-19.

According to the Centers for Disease Control, COVID-19 is mainly spread person to person through respiratory droplets produced when an infected person coughs or sneezes. Other means of virus transmission are possible as well. Asymptomatic patients or patients who have not yet presented with symptoms may transmit the virus to others, and the virus may also be spread by contacting a contaminated surface.

Symptomology Related to COVID-19

Some people with COVID-19 remain asymptomatic carriers of the disease, while others exhibit varying degrees of the following common symptoms:

  • Fever
  • Cough
  • Shortness of breath
  • Gastrointestinal Complaints
    • Diarrhea
    • Abdominal pain
    • Vomiting
  • Anorexia (loss of appetite)

 
 


REFERENCES – Offsite Links Open in New Window

  1. Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H. "Evidence for gastrointestinal infection of SARS-CoV-2". Gastroenterology. 2020.
  2. "Prolonged Presence of SARS-CoV-2 Viral RNA in Faecal Samples", last modified March 19, 2020, accessed March 30, 2020.
  3. Diagnostic Value and Dynamic Variance of Serum Antibody in Coronavirus Disease 2019 (April 3, 2020), accessed April 15, 2020
  4. Profile of Specific Antibodies to SARS-CoV-2: The First Report, last modified March 21, 2020, accessed April 15, 2020

 


Updated 7/23/2020

 

Diagnostic Solutions Laboratory is CLIA Certified

In addition to our internal quality control and validation processes, Diagnostic Solutions Laboratory is CLIA certified. CLIA certification ensures that our laboratory meets or exceeds U.S. standards set for laboratory excellence.

 

 

Articles

Novel Coronavirus COVID-19 IgG and IgM ELISA Tests Performed by Diagnostic Solutions Laboratory
This PDF document provides technical information about the COVID-19 IgG/IgM Antibody Test used by Diagnostic Solutions Laboratory.


Coronavirus Stool Testing:
SARS-CoV-2 qPCR Stool Test from Diagnostic Solutions Laboratory

 

Health Organizations

The following links to external sites are provided for your convenience and contain the latest information related to COVID-19. These links will open in a new browser window/tab so that you don't lose your place on this page.

 

 
 

Sample Report