Antibody Test (Biozek)

Biozek’s Rapid IgM-IgG Antibody Test Cassette for COVID-19 is a lateral flow immunoassay. It is used to qualitatively detect IgG and IgM antibodies of the virus in whole blood. This clinically proven 10-minute antibody test allows us to identify if you have had Covid-19 by detecting the presence of antibodies.

We are one of the first companies to introduce such rapid testing (ref BNCP-402). The product is Dutch in origin and has CE certification, SFDA approval and, according to the MHRA regulatory bodies, the “product can be placed on the UK market for professional use only”.

BIOZEK COVID-19 IgG/IgM Rapid Test Offers:

• High accuracy with more than 9% accuracy
• Fast results with 10-minute assay time
• Simple process with limited equipment needed

COVID-19 – The pandemic

On March 11, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization (WHO). Current information on the SARS-CoV-2 virus and COVID-19 disease for including case definitions and information about signs and symptoms is available at https://www.who.int/health-topics/coronavirus#tab=tab_1

According to the “Policy paper Coronavirus (COVID-19): scaling up testing programmes” released by the MHRA UK on the 4th of April 2020; their mission is to introduce the use of rapid antibody tests for use by healthcare professionals and by people at home.

Why do I need an antibody test?

Antibody testing is quick and simple, with results being available within 15 minutes of blood sampling. It is a great way to screen staff and can be comforting for individuals self-isolating at home. Those who are deemed ‘immune’ will be greatly encouraged. Those who are not immune will be advised and guided on further testing and re-testing in the future. Most individuals who have experienced symptoms are likely to be immune, but an antibody test is often required to be sure.

How accurate is the test?

Overall, the test has an accuracy of more than 92.9%.

Will I understand my results?

The results of the test will be analysed by medical doctors and your immune status to the virus will be carefully evaluated. The outcomes will be explained to you in depth and we are happy to answer any of your queries during our consultation ‘post- testing’.

In short, we will be testing for 2 types of antibodies; the IgM and IgG antibodies:

The presence of IgM indicates that you will have had the infection within a 28-day period (with or without symptoms).

The IgG antibodies lasts in the human body and is present in the blood for several years – hence this demonstrates potential immunity to the virus.

Note: Although not confirmed, science suggests that a re-exposure to the virus at a later date can stimulate a ‘booster effect’; the levels of IgG/IgM may vary at this time for approximately 7 days.

Scenario	IgM	IgG	Clinical interpretation and Comments
1	NEG	NEG	No infection
2	POS	NEG	Possible early infection
3	POS	POS	Definite infection (recovering)
4	NEG	POS	Past infection

COVID-19 Antibody Test (IgG and IgM)
Cost of Test	£90
Accuracy of Test	98% sensitivity 98% specificity
Origin of Test	Biozek, Holland
Availability: i.e. testing can commence and can accommodate large numbers	Available Large Numbers Possible
Turnaround time of results	10 minutes
Onsite visits and or postal for homeworkers	Onsite possible Not approved for postal usage
Certifying bodies	MHRA compliant and CE mark
Notes	Public Health England do not approve medical diagnostic devices

The test requires a finger-prick blood sample to be collected and sent back to us for testing

Inside your home testing package, you will find:

• A gold-topped blood collection tube
• A pack of lancets to prick your finger
• Pre-lancet antiseptic wipes and plasters
• A pathology form
• A postage-paid envelope to return your sample to the laboratory

The Abbott Laboratories’ COVID-19 IgG antibody testing kit uses a globally certified diagnostic laboratory facilities to test for past exposure to the COVID-19 virus. This test has confirmed to be

95% accurate in identifying antibodies at 14 days after the onset of symptoms.

 

COVID-19 Antibody Test (Lab) IgG
Cost of Test	£120
Accuracy of Test	>95% sensitivity >95% specificity
Origin of Test	Abbott Laboratories
Availability: i.e. testing can commence and can accommodate large numbers	Available Large Numbers Possible
Turnaround time of results	24 hours
Onsite visits and or postal for homeworkers	Onsite possible Approved for postal usage
Certifying bodies	FDA (EUA) approved MHRA compliant and CE mark
Notes	Public Health England approved medical diagnostic devices

The test requires a finger-prick blood sample to be collected and sent back to our accredited UK laboratory for testing.

Inside your home testing package, you will find:

• A gold-topped blood collection tube
• A pack of lancets to prick your finger
• Pre-lancet antiseptic wipes and plasters
• A pathology forms
• A postage-paid envelope to return your sample to the laboratory

What is a PCR test?

Polymerase chain reaction tests, known as PCR, are the most customary test for determining whether someone is currently infected with COVID-19.

How do they work?

The COVID-19 PCR test works by obtaining a throat swab or sputum sample from an individual using a long thin nasopharyngeal swab. That swab is stored in a sterile tube or vial and is then sent to a lab for processing.

Why is this test important?

The PCR test is the most widespread and most accurate diagnostic test for determining whether someone is currently infected with coronavirus. People who test positive for the virus can quarantine and isolate themselves and keep it from spreading to others. The test does not reveal the presence/absence of previous infection with COVID-19, it only reveals the presence of current infection.

 

COVID-19 PCR antigen swab test
Cost of Test	£120-£150
Accuracy of Test	99%
Origin of Test	Laboratory, UK
Availability: i.e., testing can commence and can accommodate large numbers	Available Large Numbers Possible
Turnaround time of results	48 TO 72 hours
Onsite visits and or postal for homeworkers	Onsite possible Approved for postal usage
Certifying bodies	MHRA compliant and CE mark
Notes	Public Health England do not approve medical diagnostic devices

This Covid-19 home test requires a combined nose/throat swab sample to be collected and sent back to our accredited UK laboratory for testing.

 Inside your home testing package, you will find:

• A sterile PCR swabs
• A pathology forms
• A transparent sealable bag
• A full set of sample collection and how to return your swab instructions
• Postage-paid return envelope to the laboratory