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Summary and Explanation of the Test
COVID-19 (coronavirus disease 2019) is the disease caused by SARS-CoV-2 (severe acute
respiratory syndrome coronavirus 2) viral infection.
1
The virus is readily transmitted from
both symptomatic and presymptomatic
2-4
individuals via respiratory droplets, aerosols, and
upper respiratory secretions.
5-6
The incubation period is estimated to be 4.6–5.8 days with
a median of ~5 days.
7
The symptoms of COVID-19 are non-specific, ranging from
asymptomatic to severe pneumonia and death.
8
Fever and cough are the most common
clinical symptoms but also include shortness of breath, fatigue, muscle aches, headache,
new loss of smell or taste, sore throat, congestion or runny nose, diarrhea, and vomiting,
which typically appear between 2–14 days following exposure to the virus.
8-10
Roughly 20%
of those infected with SARS-CoV-2 will experience severe symptoms, including Acute
Respiratory Distress Syndrome (ARDS) that often requires mechanical ventilation.
11
The standard medical practice for definitive diagnosis of active SARS-CoV-2 infection relies
on the molecular detection of viral RNA.
12-14
Typically, IgA and IgM production occur
simultaneously and shortly after viral infection with IgM ebbing rapidly in convalescence.
15-
16
IgG antibody responses occur after IgM and IgA seroconversion and are longer
sustained.
17
The QIAreach™ Anti-SARS-CoV-2 Total Test detects total antibodies to SARS-
CoV-2 and is an indirect test for indicating recent or prior infection in populations of
interest. The clinical and public health applications of serologic assays may include support
to clinical assessment in persons suspected of having a post-infectious syndrome and
understanding transmission dynamics in populations.
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Principles of the assay
The QIAreach™ Anti-SARS-CoV-2 Total Test is a rapid, qualitative serological test that
detects total antibody responses to expressed SARS-CoV-2 viral antigens, in serum or
plasma (sodium heparin, lithium heparin, dipotassium EDTA and tripotassium EDTA).
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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