Genica Molecular Testing for Acute Respiratory Tract Infections
Respiratory Infections

Molecular Testing for Acute Respiratory Tract Infections

Respiratory infections are the most common reason for visit to the doctor. Many respiratory diseases are self-limiting viral infections that resolve over time and through supportive care. However, it is often crucial to identify the causative agent at an early stage of the disease in order to implement effective antimicrobial therapy and infection control. In addition, tests that identify the form of infection (viral, bacterial, or mixed etiology) supports infections control and informative decision whether an antibiotic is needed.

In the last few years, with the development of new analyzes and the availability of updated tests for newer strains of pathogens, the diagnosis of respiratory infections has significantly developed. Newer laboratory methods are fast, highly sensitive and specific, and are gradually replacing conventional gold standards. Nucleic acid amplification tests (PCR) for respiratory viruses are already used to detect both conventional and emerging viruses. These tests are more sensitive than other diagnostic approaches, with the PCR method forming the backbone of clinical virological laboratory tests. It allows up to 21 different viruses to be detected in one test, distinguishing between emerging viruses, such as SARS-CoV-2 (COVID-19), influenza and cold.

COVID-19

COVID-19 PCR

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.

Diagnostic Range: SARS-CoV-2

Diagnostic Method: RT-PCR assay

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: Same day results for all COVID-19 PCR tests and immunological tests for SARS-CoV-2 antibodies. Test results for antigen analysis are issued within 1 hour after sample collection.

Fee: COVID-19 PCR Individual - BGN 90; COVID-19 PCR Family Package - BGN 75 per patient; COVID-19 PCR 2+ Group Package - BGN 75 per patient.

Clinical application

 Diseases associated with SARS-CoV-2  

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COVID-19

COVID-19 Antigen Test

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.

Diagnostic Range: SARS-CoV-2

Diagnostic Method: Viral capsid detection

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: 1 hour

Fee: BGN 35

Clinical application

Diseases associated with SARS-CoV-2 

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Quantitative Tests for SARS-CoV-2 Antibodies

Neutralizing COVID-19 Antibodies

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.

Diagnostic Range: Spike protein - RBD domain

Diagnostic Method: ELISA IgG

Research Material: Venous blood

Results within: Same day

Fee: BGN 50

The test is recommended to:

  • Individuals who have recovered from COVID-19 to evaluate the presence of neutralizing antibodies
  • Potential donors of hyperimmune plasma for therapeutic purposes
  • Vaccinated individuals to evaluate the production of neutralizing anti Spike / RBD IgG antibodies 
  • The general population - in the context of epidemiological studies

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Quantitative Tests for SARS-CoV-2 Antibodies

Binding COVID-19 Antibodies

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.

Diagnostic Range: Nucleocapsid protein

Diagnostic Method: ELISA IgG

Research Material: Venous blood

Results within: For samples taken before 1.00 p.m. - the same day. For samples taken after 1.00 p.m. – before 2.00 p.m. the next business day.

Fee: BGN 30

Clinical application

Immune response against SARS-CoV-2

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Combined PCR Test for Acute Viral Respiratory Infections

COVID-19 + Influenza A and Influenza B (PCR Test)

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.

Diagnostic Range: SARS-CoV-2; Influenza A; Influenza B

Diagnostic Method: RT-PCR Assay

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: For samples taken before 1.00 p.m. - the same day. For samples taken after 1.00 p.m. – before 2.00 p.m. the next business day.

Fee: BGN 135

Clinical application

SARS-CoV-2; Influenza A; Influenza B

Combined PCR Test for Acute Viral Respiratory Infections

COVID-19 + Influenza A and Influenza B + RSV (PCR Test)

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.

Diagnostic Range: SARS-CoV-2; Influenza A; Influenza B; RSV

Diagnostic Method: RT-PCR Assay

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: For samples taken before 1.00 p.m. - the same day. For samples taken after 1.00 p.m. – before 2.00 p.m. the next business day.

Fee: BGN 140

Clinical application

COVID-19, influenza A and influenza B, non-influenza acute respiratory infections

Combined PCR Test for Acute Viral Respiratory Infections

ARVI Screen 18®

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.

Diagnostic Range: SARS-CoV-2; Influenza A; Influenza B; Human Respiratory Syncytial virus (hRSv); Human Metapneumovirus (hMpv); Human Parainfluenza virus-1-4 (hPiv); ОС43, Е229, NL63, HKUI human Coronavirus (hCov); Human Rhinovirus (hRv); Human B, C, E Adenovirus (hAdv); Human Bocavirus (hBov)

Diagnostic Method: PCR Assay

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: Up to 24 hours

Fee: BGN 140

Clinical application

COVID-19; Acute respiratory viral infections

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Acute Respiratory Viral Infections

ARVI Screen 22®

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.

Diagnostic Range: SARS-CoV-2; Influenza A; Influenza B; Human Respiratory Syncytial virus (hRSv); Human Metapneumovirus (hMpv); Human Parainfluenza virus-1-4 (hPiv); ОС43, Е229, NL63, HKUI human; Coronavirus (hCov); Human Rhinovirus (hRv); Human B, C, E Adenovirus (hAdv); Human Bocavirus (hBov); Enterovirus (EV); Parechovirus (HPeV); Paramyxoviridae (HPIV)

Diagnostic Method: PCR Assay

Research Material: Nasopharyngeal and oropharyngeal specimens

Results within: Up to 48 hours

Fee: BGN 190

Clinical application

COVID-19; Acute respiratory viral infections

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Acute Bacterial Respiratory Infections

Bacterial Respiratory Panel PCR

The test is intended for patients with symptoms of acute respiratory infection with suspected bacterial or mixed viral and bacterial etiology. 

The test results provide information to the physician about the type of pathogen that causes the respiratory. 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.

Diagnostic Range: Mycoplasma pneumoniae; Chlamydophila pneumoniae; Legionella pneumophila; Haemophilus influenzae; Streptococcus pneumoniae; Staphylococcus aureus; Moraxella catarrhalis

Diagnostic Method: PCR Assay

Research Material: Nasopharyngeal and oropharyngeal specimens; Sputum

Results within: Up tp 24 hours

Fee: BGN 95

Clinical application

Acute respiratory bacterial infections; Bacterial pneumonia

Analysis of CFTR Gene Mutations

Mucoviscidosis / Cystic Fibrosis

Mucoviscidosis / Cystic fibrosis is an inherited, incurable disease with a high incidence among Caucasians. It is due to mutations in the CFTR gene, which leads to disruption of chloride channels on the secretory glands. As a result, excessively thick and sticky mucus is retained and accumulated, that is a favorable environment for the development of pathogenic microorganisms and for frequent infections. Many systems and organs are affected - most often the lungs and the digestive system.

Symptoms may occur before birth (with ultrasound evidence of hyperechogenic intestinal loops in the fetus), after birth (the most common indication is meconium ileus), or in early childhood (with frequent severe lung infections and slow weight gain). The treatment is supportive, and the hope in some cases is in a lung transplant. The average life expectancy of the affected patients is between 12 and 30 years.

The frequency of mutations in the CFTR gene among the Bulgarian population is estimated at 1 in 30 (or about 200,000 persons in the country), and every year an average of 20 children are born affected by this incurable disease.

The risk of giving birth to a child affected by cystic fibrosis in a family with both partners carriers is 25%. The only prevention is search for carriers and prenatal diagnostics.

Diagnostic Range: CFTR

Diagnostic Method: Sanger sequencing to search for point mutations and small deletions in the CFTR gene; MLPA to search for deletions of exons of the CFTR gene

Research Material: Venous blood with K2EDTA (purple tube)

Results within: 10 business days

Fee: BGN 420 - Sanger sequencing to search for the most common CFTR mutations in Bulgaria; BGN 2,600 - Sanger sequencing of the entire CFTR gene; BGN 800 - MLPA

Clinical application

Confirmation of the clinical diagnosis; Carrier testing in unaffected family members