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SARS-CoV-2: An overview of virus structure, transmission and detection
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to more severe ones such as Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2 1,2.
SARS-CoV-2 is transmitted from person-to-person primarily via respiratory droplets, while indirect transmission through contaminated surfaces is also possible3-6. The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is most abundant in the lungs7,8.
The incubation period for COVID-19 ranges from 2 – 14 days following exposure, with most cases showing symptoms approximately 4 – 5 days after exposure3,9,10. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical11,12. While most symptomatic cases are not severe, severe illness occurs predominantly in adults with advanced age or underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized by e.g., respiratory failure, shock and/or multiple organ dysfunction, or failure.
The benefit of having a SARS-CoV-2 antigen test available
The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).1 At these locations viral load peaks within the first week after symptom onset, and then declines.2
A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
At Roche Diagnostics we believe wide accessibility to such high-performance, instrument-free and reliable Point of Care tests can contribute significantly to better managing the ongoing pandemic crisis.
Features and benefits of the SARS-CoV-2 Rapid Antigen Test Nasal
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure.1 This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.
Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
The benefits of the SARS-CoV-2 Rapid Antigen Test Nasal in short:
- Using a nasal swab for quick and convenient specimen collection
- Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
- Providing patients with the option to self-collect their nasal sample
- Allowing decentralized testing or access to testing in areas where laboratory testing is not available.
Test kit information
The kit is ready for use and contains all equipment needed to perform a test. The following components are needed for a test and included in the kit:
- Test device (individually in a foil pouch with desiccant)
- Extraction buffer tube and buffer tube rack
- Nozzle cap
- Sterile swab
- Instructions for use and Quick Reference Guide
- Positive and negative controls
SARS-CoV-2 Rapid Antigen Test Nasal
- The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the
qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in human nasal swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease.
- Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and
should not be used as the sole basis for treatment or patient management decisions, including
infection control decisions. Negative results should be considered in the context of a patient’s recentexposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or
self-collection under the supervision of a healthcare worker.
with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In
more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure,
and even death. In late 2019 a new coronavirus, later named SARS-CoV-21
, was identifi ed in a cluster of pneumonia cases, and the World Health Organization described the global SARS-CoV-2 situation as pandemic on March 11, 20202. The disease associated with SARS-CoV-2 infection was named COVID-19 (COronaVIrus Disease 2019)3
PRINCIPLE OF THE TEST
on the surface of the nitrocellulose membrane. Both the control line and test line in the result
window are not visible before applying any samples. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and mouse monoclonal anti-Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARS-CoV-2 antibody conjugated with color particles are used as detectors for the SARS-CoV-2 antigen device.