Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2


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SARS-CoV-2 Rapid Antigen Test

Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx


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An aid in identifying individuals infected by SARS-CoV-215

 

The SARS-CoV-2 Rapid Antigen kiểm tra is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. 

This test is an aid in detecting antigen from the SARS-CoV-2 virut in individuals suspected of COVID-19. This sản phẩm is strictly intended for professional use in laboratory & Point of Care environment. 


SARS-CoV-2: An overview of virus structure, transmission và detection

 

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA vi khuẩn of the family Coronaviridae. Coronaviruses giới thiệu structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), & nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to lớn 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 vi khuẩn accesses host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is most abundant in the lungs7,8.

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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 & taste, shortness of breath) to lớn 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 failure11,13,14. 


Definite COVID-19 diagnosis entails direct detection of SARS-CoV-2 RNA by nucleic acid amplification công nghệ (NAAT)21-23. Serological assays, which detect antibodies against SARS-CoV-2, can contribute to lớn identify individuals, which were previously infected by the virus, và to assess the extent of exposure of a population. They might thereby help khổng lồ decide on application, enforcement or relaxation of containment measures24.

Upon infection with SARS-CoV-2, the host mounts an immune response against the virus, including production of specific antibodies against viral antigens. Both IgM & IgG have been detected as early as day 5 after symptom onset25,26. Median seroconversion has been observed at day 10 - 13 for IgM & day 12 - 14 for IgG27-29, while maximum levels have been reported at week 2 - 3 for IgM, week 3 - 6 for IgG và week 2 for total antibody25-31. Whereas IgM seems to lớn vanish around week 6 - 732,33, high IgG seropositivity is seen at that time25,32,33. While IgM is typically the major antibody class secreted to lớn blood in the early stages of a primary antibody response, levels & chronological order of IgM and IgG antibody appearance seem to lớn be highly variable for SARS-CoV-2. Anti-SARS-CoV-2 IgM & IgG often appear simultaneously, and some cases have been reported where IgG appears before IgM, limiting its diagnostic utility26,27,29,34,35. 

After infection or vaccination, the binding strength of antibodies to lớn antigens increases over time - a process called affinity maturation36. High-affinity antibodies can elicit neutralization by recognizing and binding specific viral epitopes37,38. In SARS-CoV-2 infection, antibodies targeting both the spike và nucleocapsid proteins, which correlate with a strong neutralizing response, are formed as early as day 9 onwards, suggesting seroconversion may lead to protection for at least a limited time34,39-42.


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Testing ready to lớn go when you need to lớn know

 

The reliable SARS-CoV-2 Rapid Antigen demo provides fast answers wherever you need them. It’s time lớn expand testing- because patients & their communities need to know.


The benefit of having aSARS-CoV-2 antigen test available

 

The SARS-CoV-2 vi khuẩn causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, và primary viral replication is presumed lớn occur in mucosal epithelium of the upper respiratory tract (nasal cavity & pharynx).1 At these locations viral load peaks within the first week after symptom onset, & then declines.2

A SARS-CoV-2 antigen kiểm tra 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 thử nghiệm identifies current infection during the acute phase of COVID-19, while the vi khuẩn is still present in large quantities in the respiratory tract.

 

Features và benefits of the SARS-CoV-2 Rapid Antigen Test

 

Besides laboratory PCR testing, antigen assays can also be offered as rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen chạy thử is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS‑CoV‑2 present in nasopharyngeal or combined nasopharyngeal/oropharyngeal samples. This kiểm tra is intended to detect antigen from the SARS‑CoV‑2 virus in individuals suspected of COVID‑19. This sản phẩm is strictly intended for professional use in laboratory và Point of Care environments. Similar khổng lồ laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to lớn assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.

 

The SARS-CoV-2 Rapid Antigen chạy thử enables fast decision making e.g. Whether patients need khổng lồ be put in quarantine, reducing the risk of further spreading. In addition to lớn that it allows for screening of individuals after confirmed exposure to lớn a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.

 

The SARS-CoV-2 Rapid Antigen kiểm tra allows for decentralized testing at the point of care & helps to lớn expand the range & quantity of direct vi khuẩn testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition khổng lồ that, the SARS-CoV-2 Rapid Antigen test is an instrument không tính tiền test, allowing testing in rural/ low-infrastructure areas.

 

The benefits of the SARS-CoV-2 Rapid Antigen test in short:

 

Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result Easy handling which does not require specific training No instrument required Allowing decentralized testing or access to testing in areas where laboratory testing is not available

 


1. Collecting a sample (nasypharyngeal swab)*

 

Insert a sterile swab into the nostril of the patient & then rotate the swab 3-4 times against the nasopharyngeal surface. Withdraw the swab from the nasal cavity.

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*When collecting a combined NP/OP sample be sure khổng lồ follow the procedures described in the Instructions for Use.


2a. Preparing a sample

 

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.


2b. Preparing a sample

 

Remove the swab while squeezing the sides of the tube to lớn extract the liquid from the swab.


2c. Preparing a sample

 

Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.


3a. Performing a test

 

Place the kiểm tra device on a flat surface & apply 3 drops of extracted sample in a 90° angle to lớn the specimen well of the demo device.


3b. Performing a test

 

Read the thử nghiệm result at 15 khổng lồ 30 min.

Warning: Risk of incorrect results. Bởi vì not read the chạy thử result after 30 min.


4. Interpreting results

 

A colored line appears in the đứng top section of the result window to lớn show that the demo is working properly. This is the control line (C). Even if the control line is faint, the kiểm tra should be considered to have been performed properly. If no control line is visible the chạy thử is invalid. 

In case of a positive result, a colored line appears in the lower section of the result window. This is the kiểm tra line (T). Even if the demo line is very faint or not uniform, the thử nghiệm result should be interpreted as a positive result.