SARS-CoV-2 TEST SYSTEMS

The RT-PCR test for COVID-19 is the global standard for diagnosing coronavirus. This is a molecular genetic test that uses a technique to amplify small, SARS-CoV-2-specific DNA fragments. It can be used to determine whether the test material contains genetic material of the virus, even in small quantities. The test is performed on nasopharyngeal and oropharyngeal sample (nasal and throat sample). 

The PCR test is the earliest diagnostic marker for COVID-19. It detects the pathogen in subclinical or asymptomatic forms, even before the virus carrier is able to transmit the infection to others. By extracting the carrier of genetic information (RNA) of the virus and subsequent detection by RT-PCR of several genes, unique and specific for SARS-CoV-2, GENICA Lab delivers results of a PCR test using the highest-class laboratory analysis. GENICA’s RT-PCR test for SARS-CoV-2 meets the high analytical criteria for а genetic laboratory. It detects highly sensitive unique genes, specific only for this virus, guaranteeing the accuracy and precision of the results.

GENICA holds INSTAND E.V. certificate for international quality of laboratory diagnostics for SARS-CoV-2.

COVID-19 antigen assays look for the antigen in the virus envelope protein. These tests are faster than PCR diagnostics but have lower sensitivity and specificity than the PCR test, because they do not multiply the in-vitro viral antigen (as in the PCR method) but detect the actual viral amount in the sample. Due to the lack of viral replication the rapid antigen test is applicable to patients with a high viral load. These tests are a good screening choice for patients with symptoms. The best time for testing is about a week after possible risky contact with a positive patient or during the first week of clinical symptoms. A negative result does not rule out the possibility of COVID-19 infection and should be interpreted in conjunction with the clinical picture, patient history, and epidemiological information. In case of clinical and epidemiological data, regardless of the negative result of the rapid antigen test, PCR must be performed.

The US company GeneScript®'s cPassTM is a test to detect virus-neutralizing SARS-CoV-2 antibodies, the only one approved by the US Food and Drug Administration (FDA) and the European CE-IVD regulatory authorities for in vitro diagnostics. This test detects the presence and amount of certain antibodies associated with blocking the virus's ability to infect human cells. Therefore the test demonstrates immunity and real seroprotection against infection with the virus that causes COVID-19. All other available tests denote only the detection of antibodies as a concomitant serological marker for a past infection or as an adjunct diagnosis for COVID-19. Neutralizing bodies are formed in the body from 14 to 45 days after infection, depending on the individual immunological response of each organism. Therefore, the test is not recommended to be applied earlier than 2 weeks after confirmed PCR infection or symptoms manifested. The accuracy of the test to detect neutralizing antibodies is 99.6%.

The cPassTM GeneScript® test for anti-SARS-CoV-2 VNT (virus neutralizing antibody) can show whether a person has built up protection against the infection after recovering from it or after being vaccinated.

A positive result from the cPassTM test conveys the presence of over 30% of virus neutralizing antibodies and such result is observed in a large proportion of recovered and vaccinated individuals. The positive result is related to the efficacy of the immunity acquired from COVID-19 after vaccination or infection, and is perceived as a marker for protection against reinfection. Virus neutralizing antibody quantities shows decreasing trend over time, which is individual to each patient.

A negative result (value below 30%) indicates the absence of these antibodies after recovery from COVID-19, or that they are in very low concentrations. Thus the patient is likely to be infected. A negative result can be a very important indicator for timely vaccination.

During a respiratory viral infection, SARS-CoV-2 first infects the cells of the oropharynx and nasopharynx, as the newly formed virus particles are released from the infected cells and enter the salivary secretions. In this way, when a person talks, coughs, sneezes, he/she spreads the virus to the surrounding area, infecting the people around him/her. Following the course of viral infection, saliva stands out as one of the preferred materials for the study of COVID-19.

The PCR saliva test has high sensitivity and specificity. It is non-invasive, completely safe and with zero discomfort for the patient.

Saliva is more sensitive than nasopharyngeal swabs for the diagnosis of asymptomatic and mild COVID-19 infection. It is at least as sensitive as the nasopharyngeal swab in severe COVID-19 infection, according to recent studies published in medical journals.

Saliva PCR test results are recognized worldwide.

Binding antibodies tests are useful as diagnostic indicators whether an individual has been infected. They do not indicate whether the infection is current or past. The COVID-19 Binding Antibodies Test is NOT used to diagnose active infection or asymptomatic carriers. In case of a positive test for binding SARS-CoV-2 antibodies, a PCR test is performed to rule out active infection. The Binding Antibodies Test can show whether a person has been in contact with the virus. It cannot distinguish the presence of neutralizing antibodies that are associated with established immunity against SARS-CoV-2.

This test offers simultaneous testing for COVID-19, influenza A and influenza B with a single sample of nasopharyngeal or oropharyngeal specimen (nasal or throat sample). The technology is the same as in the RT-PCR tests for COVID-19. It differs in that there are several different primer and fluorescent probes specifically targeted at: influenza virus matrix protein type A (Flu A), influenza virus type B matrix protein (Flu B), and nucleocapsid gene N of SARS-CoV-2 virus.

This type of test is recommended by the WHO for the specific diagnosis and differentiation of the three viruses as causes of acute respiratory disorders with similar symptoms but with different causes and different treatments.

This test offers simultaneous testing for COVID-19, influenza A, influenza B and respiratory syncytial virus (RSV) with a single sample of nasopharyngeal or oropharyngeal specimen (nasal or throat sample). The technology is the same as in the RT-PCR tests for COVID-19. It differs in that there are several different primer and fluorescent probes specifically targeted at: influenza virus matrix protein type A (Flu A), influenza virus type B matrix protein (Flu B), RSV and nucleocapsid gene N of SARS-CoV-2 virus.

These types of tests are recommended by the WHO for the specific diagnosis and differentiation of the four viruses as causes of acute respiratory disorders with similar symptoms but with different causes and different treatments.

PCR test for simultaneous detection of 18 pathogens associated with acute respiratory viral infections. It includes testing for the new coronavirus, the two influenza and 15 non-influenza viruses. 

The test detects a number of respiratory viruses associated with influenza and non-influenza respiratory infections, distinguishing them from SARS-CoV-2, that causes COVID-19. In addition to SARS-CoV-2, influenza virus type B and three separate strains of influenza virus type A, the test detects four other coronaviruses, human metapneumovirus, human rhinovirus, adenovirus, bocavirus, parainfluenza virus, respiratory syncytial virus (RSV).

The test results provide information to the physician about the type of pathogen that causes the respiratory disease (viral, bacterial, or mixed etiology). This allows for an informed assessment of the therapeutic approach for the patient - for example, the need for anti-influenza drugs, antibiotics or only symptomatic treatment and more.

This is PCR test for simultaneous detection of 22 pathogens associated with acute respiratory viral infections. It includes testing for the new coronavirus, the two influenza and 19 non-influenza viruses, covering all possible respiratory viral pathogens.

ARVI screen 22® detects a number of respiratory viruses associated with influenza and non-influenza respiratory infections, distinguishing them from SARS-CoV-2, that causes COVID-19. In addition to SARS-CoV-2, influenza virus type B and three separate strains of influenza virus type A, the test detects four other coronaviruses, human metapneumovirus, human rhinovirus, adenovirus, bocavirus, parainfluenza virus, respiratory syncytial virus (RSV), parechovirus and paramyxovirus.

The test results provide information to the physician about the type of pathogen that causes the respiratory disease (viral, bacterial, or mixed etiology). This allows for an informed assessment of the therapeutic approach for the patient - for example, the need for anti-influenza drugs, antibiotics, or only symptomatic treatment and more.