Cellex q Rapid Test receives FDA (Emergency Use Authorisation)
Why Choose Cellex Covid-19 Antibody q Rapid Test
First Serology (Antibody) test to receive FDA (Emergency Use Authorization) April 1 2020
CE-IVD Mark (EC Registration Certificate)
GMP Manufacturing ISO 13485 certified, in compliance with US FDA’s QSR.
The test principle is developed by Cellex Inc. US a well-respected diagnostics and biopharmaceutical company since 2002.
Accurate (sensitivity/specificity: 98%/100%) COVID-19 results in 15 minutes.
(IMR Evaluation report)
IgG and IgM antibody test, indication of recent or past infection.
Completed third parties independent serology survey of prevalence studies in US.
For health care providers & professional use only.
AUTHORISED FOR EUA
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.
Cellex q Rapid Test
Right Test @ Right Time
Affordable for different health care systems: Test can be used anywhere, no specialized training is required
Accurate and reliable results, robust performance.
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 :
The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
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.
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).
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)
Critical for binding of host cell receptors to facilitate entry of host cell
Envelope small membrane protein (E)
Interacts with M to form viral envelope
Bound to RNA genome to make up nucleocapsid
Associated with a nucleoprotein within a capsid comprise of matrix protein
Membrane protein (M)
Central organiser of CoV assembly
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.