Updated: Jan 14, 2021
Clinic Solutions SARS-CoV-2 Total Ab assay is a semi-quarantitative diagnostic test, in a one-step antigen capture format, for the detection of IgM/IgG antibodies to the SARS-CoV-2 in human DNA.
Molecular Testing is also done to see if you currently have SARS-CoV-2 virus. The testing uses a recombinant SARS Protein in a one-step antigen capture format assay.
Results from the SARS-CoV-2 Total Ab assay should not be used as the sole basis for diagnosis considering tests results can vary from facility to facility. Also the US Government is requiring that all specimens should be collected in CLIA certified laboratories and/or by healthcare workers at the point-of-care to report their numbers and results for claimed accuracy and statistical purposes.
SUMMARY AND EXPLANATION OF THE TEST
Coronavirus (CoV) is an enveloped virus that contains a single-stranded positive-sense RNA. SARS-CoV-2, formerly known as 2019-nCoV, is a newly emerging coronavirus that mainly affects the respiratory tract that can lead to Severe Acute Respiratory Syndrome (SARS). The underlying disease caused by this virus is named COVID-19. Corona viruses have been responsible for several outbreaks in the world during the two last decades. In 2003 and 2014, corona viruses caused outbreaks mainly in Asia (SARS-CoV) and in the Middle East (MERS-CoV), respectively. Before the new SARS-CoV-2 emergence, six corona viruses were known to affect humans (SARS-CoV, MERS-CoV and four other corona viruses that cause mild upper and lower respiratory syndromes).
SARS-CoV-2 was first identified in December 2019, in Wuhan City, Hubei Province, China, after several patients developed severe pneumonia similar to that caused by SARS-CoV. The virus has since rapidly spread around the globe and in March 2020, WHO officially announced COVID-19 as a pandemic. Person-to-Person transmission of the virus lead to quick spreading of COVID-19 and a high number of patients requiring intensive care urged authorities around the world to set up containment measures. The incubation period ranges from 2 to 14 days.
The virus has been detected in respiratory secretions, considered as the primary means of transmission. Once viral particles enter the respiratory tract, the virus attached to pulmonary cells via the ACE-2 receptors followed by endocytosis. SARS-CoV-2 can also be transmitted via the fecal route.
Patients positive for SARS-CoV-2 and that are symptomatic are diagnosed with COVID-19. Symptoms can vary drastically and notably include fever, dry cough, anosmia, sputum production, headaches, dyspnea, fatigue, nausea, and diarrhea. While some cases can be asymptomatic, others can lead to acute respiratory distress syndrome (ARDS) and even death.
Diagnosis mainly relies on real-time reverse transcription polymerase chain reaction (RT-PCR) testing of respiratory specimens. However, RT-PCR could lead to false negative results due to low viral loads unsuitable collections, handling, and storage of swabs (oropharyngeal or nosopharyngeal), or failure during the reactions process. SARS-CoV-2 Total Ab detects IgM and IgG antibodies to SARS-CoV-2. In conjunction with other tests it can be used to determine if a patient has been exposed to SARS-CoV-2.