COVID-19 Tests

COVID-19 is a viral respiratory disease caused by a coronavirus called SARS-CoV-2.

Various testing tools are available to test for the disease. There is a test that can confirm or rule out the presence of the new coronavirus in a matter of hours (minutes in a rapid test).

COVID-19 Rapid test from Blood

COVID-19 lgM/lgG test

Rapid test for infection

Test methods at different stages of COVID-19 infection

The novel coronavirus (COVID-19) epidemic has spread rapidly throughout China and many other countries. Molecular biological testing has become the standard procedure for recognising the disease, which has several limitations, and reports of false negative tests have been received in many cases. There is an urgent need for an authentic and effective test method that can quickly detect large numbers of infected as well as asymptomatic carriers to prevent transmission of the virus and provide timely treatment to patients. GenBody COVID-19 IgM / IgG is a rapid chromatographic immunoassay package that detects M immunoglobulin (IgM) and G immunoglobulin (IgG) produced in the body in response to the presence of COVID-19 virus from serum, blood plasma and whole blood.

Comparison to the molecular biological method

MOLECULAR BIOLOGICAL TESTING (RT-PCR)GENBODY COVID-19 LGG / LGM QUICK TEST
Fuctional basisCOVID-19 nucleic acid testAntibody (IgM & IgG) detection in blood
Efficiency in area- China (30-50%) (Jungangilbo, 13/02/2020)
- Depends on the accuracy of sampling and the efficiency of RNA isolation
- before day 5: very low
- after day 5: 50-81% for IgM, 81-100% for IgG
Duration of test completionMore than 6 hours10 minutes
Price of testVery expensiveCommercial rates
AdministerersTrained and experiencedNormal
Samples fromThroat, mouth, nasopharynx, sputumWhole blood, blood acid, blood plasma
Testing capacityLimitedSuitable for mass-testing
Pros & Cons- Effective in the early phase
- In difficult latent or asymptomatic periods
- Adequate for a limited number of patients
- Suitable for latent or asymptomatic period
- Unsuitable between days 0 and 5 after infection
- Suitable after day 5 after infection for mass-testing patients

Diagnostic efficiency of GenBody COVID-19 IgM / IgG

PARAMETERSPERFORMANCE (CONTINUOUS)NOTES
Analytical sensitivity1.84 S / CO IgM, 1.57 S / CO IgGw. ELISA
SensitivityDay 3 after symptom: IgM- 30%, IgG- 0%w. Limited number of cases
SpecificityIgM: 98% (118/120), IgG: 99o / c (119/120)

Explanatory procedure

MOLECULAR BIOLOGICAL TESTANTIBODY TEST (IGN)ANTIBODY TEST (IGG)EXPLANATION
PositiveNegativeNegativeBetween 1st and 3rd day of acute infection
PositivePositiveNegativeBetween 3rd and 8th day of acute infection
PositivePositivePositiveBetween 8th and 15th day of infection
PositiveNegativePositiveAfter 15th day of infection or secondary infection
NegativePositiveNegativeEarly stage of infection. There is need for further molecular biology testing
NegativePositivePositiveBetween 8th and 15th day of infection. There is need for further molecular biology testing
NegativeNegativePositivePost-infection condition or (If IgG became positive after IgG negative, then) infected
NegativeNegativeNegativeNot infected

Packaging information

PRODUCT CODEPRODUCT NAMEPACKAGEBOX SIZE (MM)CARTON SIZE (MM)
COVI025 GenBody COVID-19 lgM/lgG10 tests / package160x100x75470x420x470

COVID-19 Rapid-test from nasal and throat swab

GenBody COVID-19 Ag

SARS-CoV-2 antigen detection kit from human nasopharyngeal and oropharyngeal swab samples

Intended use

GenBody COVID-19 Ag is a test based on an immunochromatographic method for the qualitative determination of SARS-CoV-2 antigen from human nasopharyngeal and oropharyngeal digests.

Explanation of the test

GenBody COVID-19 Ag is a rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 antigen from a cotton swab. The SARS-CoV-2 antigens present in the sample bind to the gold particle conjugated to the anti-SARS-CoV-2 monoclonal antibody, and then the complex binds to the anti-SARS-CoV-2 monoclonal antibody immobilized in the test region. If the sample contains SARS-CoV-2 antigen, a visible band appears in the test region of the membrane. The solution continues to flow through the membrane, reaching the control region, binding to a control conjugate, resulting in another visible band. GenBody COVID-19 Ag can also be used for direct detection of SARS-CoV-2 antigens in a cotton swab sample.

Materials provided

Materials required but not provided

Precautions

Sampling and Storage

Execution

Test Procedure
(Use of nasopharyngeal or oropharyngeal tampon *)
Use of oropharyngeal tampon is optional *
(Sample received in virus transport medium (VTM) / universal transport medium (UTM))

Interpretation of test results

(Using an analyzer)

Storage and use

Performance Features

Limit of detection (LoD): 2.87 x 10 3 TCID50 / ml (heat-inactivated medium).
Cross-reactivity: Cross-reactivity is observed with SARS-CoV-1.
There was no cross-reaction between MERS coronavirus, Human coronavirus (NL63), Human coronavirus (229E), Human coronavirus (OC43), Human Adenovirus 1, Human Adenovirus 3, Human Adenovirus 8, Human Adenovirus 18, Human Adenovirus 23, Human Adenovirus 7, Human Adenovirus 5, Human Adenovirus 11, Human Parainfluenza Virus 1, Human Parainfluenza Virus 2, Human Parainfluenza Virus 3, Human Parainfluenza Virus 4, Human Rhinovirus 1, Human Rhinovirus 14, Human Rhinovirus 42, Human Metapneumovirus, Respiratory Syncytial Virus-A, Respiratory Syncytic virus-B.

There was no interference with whole blood, mouthwash, Phenylephrine, Acetylsalicylic acid, Beclomethasone, Benzocaine, Flunisolide, Guaiacol glyceryl ether, Menthol, Oxymetazoline, Tobramycin, Zanamivir, Oseltamivir phosphate, saliva.

To evaluate diagnostic performance, a sample of 75 COVID-19 positive individuals and a sample of 276 COVID-19 negative individuals were tested (US and South Korea):

Limitations of the test

The GenBody COVID-19 Ag test is intended for primary testing of SARS-CoV-2 antigen, and is intended for point-of-care testing by clinical laboratories and healthcare professionals only, not for home use.

COVID-19 & Influenza test

GenBody Influenza/COVID-19 Ag Multi

Influenza virus (types A and B) and SARS-CoV-2 antigen detection kit from human nasopharyngeal swab

Intended use

GenBody Influenza / COVID-19 Ag Multi is a test based on an immunochromatographic method for the qualitative simultaneous detection of influenza virus (types A and B) and SARS-CoV-2 antigens from human nasopharyngeal swab.

Explanation of the test

GenBody Influenza / COVID-19 Ag Multi is a combined test for COVID-19 antigen and Influenza A and B antigens. The test is based on immunochromatography. For COVID-19, the test detects SARS-Cov-2 nucleoprotein (NP) from the cotton swab sample. A monoclonal antibody specific for SARS-Cov-2 NP was immobilized in the test zone of the membrane, in addition to another monoclonal antibody conjugated to a gold particle on the plate. If the sample contains SARS-Cov-2 antigens, they bind to the gold particle conjugated to the anti-SARS-CoV-2 monoclonal antibody and then the complex binds to another monoclonal antibody immobilized in the test region (T), resulting in a visible band. The solution continues to flow in the membrane, reaching the control region (C), where it binds to the control conjugate to form another visible band. For influenza virus, the test contains a monoclonal antibody specific for influenza A and influenza B nucleoprotein (NP) in the A and B regions of the membrane, respectively. In addition, another anti-influenza A and anti-influenza B monoclonal antibody was placed in the membrane conjugated to gold particles. If the sample contains influenza antigens, they bind to the gold particle conjugated to the anti-influenza A / B monoclonal antibody and then the complex binds to another monoclonal antibody immobilized in the test region (A / B), resulting in a visible band. The solution continues to flow in the membrane, reaching the control region (C), where it binds to the control conjugate to form another visible band. GenBody Influenza / COVID-19 Ag Multi is very useful for the direct, simultaneous detection of SARS-CoV-2 antigen and influenza A, B antigens in human swab samples.

Materials provided

Materials required but not provided

Precautions

Sampling and storage

Execution

Test procedure
(Use of nasopharyngeal or oropharyngeal tampon *)

Interpretation of test results

(Using an analyzer)

Storage and use

Performance features

1) Limit of detection (LoD): • COVID-19 Ag 2.87 x 10 3 TCID50 / ml (heat-inactivated medium). • Influenza virus type A: (H1N1) 19.53 HA units / ml, Influenza virus type A (H3N2) 20.02 HA units / ml and influenza virus type B 5.78 HA units / ml 2)

2) Cross-reactivity: COVID-19 Ag was cross-reacted with SARS-CoV-1 , Human Adenovirus 8, Human Adenovirus 18, Human Adenovirus 23, Human Adenovirus 7, Human Adenovirus 5, Human Adenovirus 11, Human Parainfluenza Virus 1, Human Parainfluenza Virus 2, Human Parainfluenza Virus 3, Human Parainfluenzavirus 4, Human Rhinovirus 1, Human Rhinovirus 14, Human Rhinovirus 42, Human Metapneumovirus, Respiratory syncytial virus-A, Respiratory syncytial virus-B. • Influenza A / B non-volatile cross-reactivity with SARS-CoV2 and SARS CoV-1, MERS coronavirus, Human coronavirus (NL63), Human coronavirus (229E), Human coronavirus (OC43), Human Adenovirus 1, Human Adenovirus 2 , measles virus, PArainfluenza virus 1, Parainfluenza virus 2, Respiratory syncytial virus, Rhinovirus, E. coli, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius

There was no interference with whole blood, mouthwash, Phenylephrine, Acetylsalicylic acid, Beclomethasone, Benzocaine, Flunisolide, Guaiacol glyceryl ether, Menthol, Oxymetazoline, Tobramycin, Zanamivir, Oseltamivir phosphate, saliva.

To evaluate the diagnostic performance of SARS-CoV-2, a sample of 30 COVID-19 positive individuals and a sample of 100 COVID-19 negative individuals were examined.

For influenza virus types A and B, a sample of 53 positive individuals for influenza type A, 62 positive individuals for influenza type B, and 176 samples for influenza negative individuals were tested to assess diagnostic performance.

Limitations of the test

The GenBody Influenza / COVID-19 Ag Multi Test is for primary testing of SARS-CoV-2 antigen and influenza virus (types A and B) antigen, and is intended for point-of-care testing by clinical laboratories and healthcare professionals only, not for home use.

EMC Global PLC. 

Plastic Face Shield

Unfortunately, masks are not 100% reliable. The face shield, on the other hand, reduces direct contact with tiny droplets and bacteria in the air, thus reducing the spread of viruses. If you need double protection, use a shield.

Advantages

Other features

Construction:

  1. Slide the edges of the cross brace through the inner gap in the face shield (1), snap it in as far as it will go, and then pull it back through the middle gap (2) from the outside. . 

  2. Do this at both ends, then knot the rubber band into the two end holes or secure the rubber band with an office stapler.  

Cleaning

General warnings

Nitrile Gloves

EMC Global PLC. 

Nitrile glove specifications

The comfortable, super-soft, flexible dust-free nitrile glove offers greater safety in many areas than other types of gloves. Designed with a special nitrile formula, it fits like latex and allows full range of motion as well as excellent flexibility to minimize stress and fatigue.

Thanks to its thickness and special material, it fits perfectly on the hand. It is powder-free, made of nitrile, so it can also be used by people who are allergic to latex, since unlike latex, it does not cause allergic reactions. It does not contain natural rubber latex and is an excellent alternative for people with type I allergies.

Description

Storage

Sizes

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