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REPRESENTATIVE OFFICE OF SD BIOSENSOR IN RUSSIA, EXCLUSIVE IMPORTER IN THE RUSSIAN FEDERATION

Description of our company’s tests

According to the research results on the effectiveness of various tests for detecting antibodies against the SARS-CoV-2 coronavirus (available upon request), it was found that the SD BIOSENSOR tests (South Korea) are among the most accurate ones. Most tests produced in Russia and China have a minimum detection sensitivity of the immunoglobulin concentration of ten to the fifth degree, whereas the SD BIOSENSOR tests have a minimum sensitivity of the immunoglobulin concentration of ten to the third degree, that is, they are 100 times more sensitive.

DETAILED description OF THE SD BIOSENSOR STANDARD Q COVID-19 AG ANTIGEN TEST:

PCR TEST ANALOGUE. NO EQUIPMENT NEEDED! STANDARD Q COVID-19 AG KIT FOR PERFORMING A REAL-TIME EXPRESS TEST FOR QUALITATIVE DETECTION OF THE CORONAVIRUS ANTIGEN IN HUMAN NASOPHARYNGEAL SMEAR SAMPLES FROM THE FIRST DAY OF SYMPTOMS.

Advantages of the test

Simplicity of administration.

Quick analysis of the results in the early stages of the disease.

Quick decision-making about isolation.

The STANDARD Q COVID-19 Ag test is a rapid chromatographic immunoanalysis for the qualitative determination of the SARC-CoV-2 antigen present in the human nasopharynx.

This test is intended only for professional use by medical professionals or in laboratories, as an aid for the early diagnosis of the SARS-CoV-2 infection in patients with clinical symptoms of the SARS-CoV-2 infection.

The test provides only a preliminary screening result.

More specific alternative diagnostic methods are needed to confirm a SARS-CoV-2 infection.

* according to the data of clinical and laboratory tests at the Moscow state medical institution ICB No. 2 DZM.

Research method is tube-free immunochromatographic analysis (IHA)

The purpose of the analysis is antigen detection

Biomaterial in nasopharyngeal smear samples

Duration of one test is no more than 30 minutes

Test results – positive/negative/invalid

No equipment is required to perform the test

Certification required: Registration certificate

Roszdravnadzor no. RZN 2020/11113 dated 02.07.2020 2020.03.10

CE Declaration of conformity

DETAILED DESCRIPTION OF THE SD BIOSENSOR STANDARD Q COVID-19 IGM / IGG ANTIBODY TEST:

EXPRESS TEST KIT FOR QUALITATIVE DETECTION AND DIFFERENTIATION OF IGM / IGG ANTIBODIES OF THE NEW SARS-COV-2 CORONAVIRUS IN HUMAN BLOOD, SERUM OR PLASMA SAMPLES.

Advantages of the test

Simplicity of administration.

Ultra fast decision on isolation and fast analysis results.

Tests determine the formation of antibodies, which is the basis for further epidemiological examination of the patient.

The STANDARD Q COVID-19 IgM / IgG Duo test is a rapid immunochromatographic test for the qualitative determination of specific SARC-CoV-2 antibodies present in human serum, plasma, or blood.

This test is intended for professional use in in vitro diagnostics of the SARS-CoV-2 infection in the recovery phase of a patient with clinical symptoms of the SARSCoV-2 infection.

* Sensitivity: when using capillary blood-92%; when using venous blood, plasma or serum, the sensitivity increases to 99%

Research method – tube-free immunochromatographic analysis (ICA)

Purpose of the analysis is identification and differentiation of IgM / IgG antibodies

Biomaterial includes capillary blood from the patient’s finger, plasma, serum, and venous blood

Time of one test – 10-15 minutes

Test results – positive/negative/invalid

No equipment is required to perform the test

Minimum package is 20 tests

Manufacturer SD BIOSENSOR, South Korea.

Certification-Roszdravnadzor Registration certificate no. RZN 2020/10742 dated 09.06.2020

Declaration of conformity: CE 2020.03.05

* according to the data of clinical and laboratory tests at the Moscow state medical institution ICB No. 2 DZM.