Cellex q Rapid Test receives FDA (Emergency Use Authorisation)
Why Choose Cellex Covid-19 Antibody q Rapid Test
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First Serology (Antibody) test to receive FDA (Emergency Use Authorization) April 1 2020
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CE-IVD Mark (EC Registration Certificate)
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GMP Manufacturing ISO 13485 certified, in compliance with US FDA’s QSR.
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The test principle is developed by Cellex Inc. US a well-respected diagnostics and biopharmaceutical company since 2002.
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Accurate (sensitivity/specificity: 98%/100%) COVID-19 results in 15 minutes.
(IMR Evaluation report)
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IgG and IgM antibody test, indication of recent or past infection.
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Completed third parties independent serology survey of prevalence studies in US.
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For health care providers & professional use only.
AUTHORISED FOR EUA
MedPath
ISO 13485
Cellex Antibody test has a high specificity to determine if a patient has had the virus and if they have developed antibodies to fight the virus.
A simple blood sample from patients can aid in identifying their immune response to SARS-CoV-2 indicating a recent or past infection.
The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test use the working test principle of Lateral flow immunoassay (LFIA) based on a sandwich method intended for the qualitative detection and differentiation of IgM and IgG antibodies which target the Nucleocapsid protein (N) and Spike Glyprotein (S) of SARS-CoV-2 in venipuncture whole blood, serum, or plasma (EDTA, citrate) specimens from patients.
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Cellex q Rapid Test
Right Test @ Right Time
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Affordable for different health care systems: Test can be used anywhere, no specialized training is required
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Accurate and reliable results, robust performance.
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Fast results allow physicians to make immediate immune response evaluation.
ANTIBODY TEST RESULT IN 15 MINUTES
CELLEX Covid-19 Antibody q Rapid test
A serology test (antibody test) such as Cellex Rapid q Rapid test is designed to help detect antibodies generated as part of the body’s immune response to fight the virus, SARS-CoV-2 coronavirus. It can deliver IgM and IgG Antibody test results in 15 minutes.
1 - The G Line and C Line are developed. This result is IgG positive or reactive, that indicates the presence of IgG anti- SARS-CoV-2
virus, consistent with a recent or previous infection. **
2 - The M Line and C Line are developed. This result is IgM positive or reactive, that indicates the presence of IgM anti- SARS-CoV-2
virus, consistent with an acute or recent SARS-CoV-2 virus infection.**
3 - All of G, M and C Lines are developed. This result is IgG and IgM positive or reactive, that indicates the presence of IgG and IgM
anti- SARS-CoV-2 virus, suggesting current or recent SARS-CoV-2 virus infection. **
4 - The C band is present, the absence of any burgundy colour in the both test bands (G and M) indicates that no anti-SARS-CoV-2
virus antibodies are detected. The result is negative or non-reactive. **
1. IgG positive 2. IgM positive 3. IgG IgM Positive 4. IgG IgM Negative
* Invalid test
If the C Line does not develop, the assay is invalid regardless of colour development of the G or M Lines as indicated below. Repeat the assay with a new device.
** Test results interpretation :
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The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
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Negative results do not prelude SAR-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
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Information regarding the immune response to SARS-CoV-2 is limited and still evolving. It is intended to be used as a screening test and aid in the diagnosis of SARS-CoV-2 viral infections. (indicating a recent or past infection).
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For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results . (Refer : WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. World Health Organization. 2010)
Ask your Doctor about Cellex Antibody Test results
Functions of Proteins
Spike glyprotein (S)
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Critical for binding of host cell receptors to facilitate entry of host cell
Envelope small membrane protein (E)
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Interacts with M to form viral envelope
Nucleoprotein (N)
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Bound to RNA genome to make up nucleocapsid
Genomic RNA
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Associated with a nucleoprotein within a capsid comprise of matrix protein
Membrane protein (M)
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Central organiser of CoV assembly
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Determines the shape of the viral envelope
The novel coronavirus detected in China in 2019 is closely related genetically to the SARS-CoV-1 virus. SARS emerged at the end of 2002 in China, and it caused more than 8 000 cases in 33 countries over a period of eight months. Around one in ten of the people who developed SARS died.
As of 24 April 2020, the COVID-19 outbreak had caused over 2 668 000 cases worldwide since the first case was reported in China in January 2020. Of these, more than 190 000 are known to have died.
As this is a new virus, no vaccine is currently available. Although work on a vaccine has already started by several research groups and pharmaceutical companies worldwide, it may be many months or even more than a year before a vaccine has been tested and is ready for use in humans.
@Britannica Inc.
