Paneles de BiofireⓇ FilmArrayⓇ

BiofireⓇ FilmArrayⓇ panels for molecular diagnosis of acute respiratory infections

By: Jairo A. Mesa Arango*, Natalia Loaiza Diaz** * Molecular Laboratory Scientist, PhDc in biology, Laboratorio Clínico Hematológico S.A. Medellín, Colombia. ** Chief of Clinical Pathology, Medical Specialist in Microbiology, Laboratorio Clínico Hematológico S.A. Medellín, Colombia. Published on 27-05-2021

Acute respiratory infections (ARI) are, according to the World Health Organization (WHO), the leading cause of morbidity and mortality due to infection in the world. It is estimated that between 290,000 and 650,000 deaths each year are associated with influenza virus infection. In the last year, the number of ARI cases has increased significantly as a consequence of the SARS CoV-2 (COVID-19) pandemic, which accounts for about 110.7 million cases of infection and more than 2.4 million deaths worldwide. All age groups are susceptible to acute respiratory infections; however, they are more prevalent in children, the elderly, and individuals with immune system disorders. These infections frequently result in the need for medical attention which, during rainy or winter periods, when they are more prevalent, tends to overload emergency and outpatient services, and increases the request for laboratory tests and other diagnostic aids, as well as the prescription and consumption of antibiotics. Although ARI can be viral or bacterial in origin, in most cases they are caused by viruses, agents that cause infections that are generally self-limiting, are not eliminated by antibiotic therapy and can easily be transmitted to others and trigger outbreaks of infection. The most frequent signs and symptoms of ARI are similar, regardless of whether they are caused by viruses or bacteria; therefore, their clinical presentation is not sufficient to reach a definitive microbiological diagnosis. Moreover, in some ARI of bacterial origin, the microorganisms are difficult to isolate and identify using conventional techniques; sometimes there is even co-infection by virus and bacteria, so it is necessary to use combined detection methodologies that allow their correct diagnosis.

Diagnosis of respiratory infections in the clinical laboratory

Traditional diagnosis:

Microbiological diagnosis of respiratory infections caused by bacteria, fungi, viruses and parasites has traditionally focused on direct microscopic visualization and culture of the microorganisms present in respiratory samples. In this way, their isolation and identification is achieved through the study of phenotypic and biochemical characteristics, and the range of susceptibility to antimicrobials, which allow the diagnosis to be established and timely clinical and pharmacological management to be carried out.

Traditional methodologies can be complemented with serological tests that directly or indirectly detect antigens of the microorganism under study, or antibodies against it, present in blood, serum or body fluid samples. This type of test is especially relevant in cases of infections caused by viruses, which are difficult to detect due to their small size (which makes microscopic visualization difficult) and their complexity for handling by culture techniques.


Traditional microbiological procedures continue to be the methods of choice for routine laboratory diagnosis, as they are cost-effective and cover the diagnosis of a significant number of infections caused by pathogenic agents or microorganisms. However, they present multiple limitations such as the execution of laborious protocols and extensive workflows (24-48 hours on average, and even days), limited performance (sensitivity/specificity), limited application in the study of microorganisms that cannot be cultured by conventional methods, and the difficulty of achieving a definitive diagnosis. The above, added to the variations that can be induced due to the technique used, the type of sample, the pathogen sought and its concentration in the sample. In addition, their detection capacity is limited to one or at most two types of pathogens simultaneously.

Molecular diagnosis:

Molecular techniques have revolutionized the way infections are diagnosed, as they allow the simultaneous detection of different species of microorganisms in the same assay (single or polymicrobial infections) and the massive study of samples. Molecular tests can be applied directly to clinical samples from patients for the detection of the nucleic acids (DNA/RNA) present, from which taxonomic identification (genus, species and subspecies or variants of the microorganism) and molecular characterization of the agent(s) involved for diagnostic purposes is possible.

Currently, techniques based on molecular biology allow cost-effective diagnoses, with greater sensitivity and specificity, and less expensive than traditional microbiological tests. Molecular diagnostic tests, in addition to favoring rapid typing of non-culturable pathogenic microorganisms, make it possible to quantify the microorganisms identified and detect genes associated with antimicrobial resistance in a matter of hours, which significantly reduces the time it takes to obtain results (8-12 hours on average) and facilitates the management and timely treatment of infections by medical personnel.

** Recently, molecular tests have been developed for the identification of pathogens that commonly cause ARI. For the most part, these tests use the polymerase chain reaction (PCR) technique to detect specific regions of the genome (DNA/RNA) of multiple microorganisms of clinical or epidemiological interest, allowing highly sensitive and specific genus- or species-level identification. The BiofireⓇ FilmArrayⓇ is a molecular diagnostic platform for easy application in clinical laboratories, based on the multiplex real-time PCR (RT-PCR) technique for the simultaneous detection of viruses and bacteria causing respiratory infections (Respiratory Panel RP2.1), from a single sample (nasopharyngeal swabs/aspirates). The workflow includes short sample handling and preparation times (2-5 minutes) and the automated run takes between 45 and 90 minutes from assembly to analysis and reporting, ensuring fast and reliable results with diagnostic utility for these infections.
alt="prueba PCR"

The BiofireⓇ FilmArrayⓇ Respiratory Panel (RP2.1) is designed to detect and differentiate the genetic material (DNA or RNA) of 22 microorganisms, 18 viruses and 4 bacteria causing respiratory infections, including RNA of the Coronavirus causing severe acute respiratory syndrome type 2 (SARS-CoV-2). Other respiratory viruses detected in the panel are: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A including subtypes H1, H3 and H1-2009, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory syncytial virus. The bacteria included are: Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae and Mycoplasma pneumoniae. 

Nucleic acids of these infectious agents are detectable in nasopharyngeal swab samples from individuals with signs and symptoms of respiratory infection during the acute phase of the disease. A positive result on the respiratory panel indicates the presence of the microorganism whose genetic material was detected and supports the diagnosis and treatment of respiratory infection when correlated with clinical and epidemiological findings. However, the detection of a microorganism in this panel does not rule out co-infection with other pathogens that are not included in this panel. Negative results may be due to RNA or DNA of the causative agent being below the detection limit of the test, to the pathogen not being part of the microorganisms evaluated in the panel, to problems in the pre-analytical phase, to the use of respiratory samples not validated for the RP2.1 panel, among others.

**In the Clinical Hematology Laboratory we have available the RP2.1 BiofireⓇ FilmArrayⓇ respiratory panel:

  1.  It allows the simultaneous detection of the genetic material (DNA/RNA) of 22 microorganisms (18 viruses and 4 bacteria) causing acute respiratory infection (including SARS-CoV-2 virus), by means of real-time multiplex RT-PCR. The detected agents are identified to genus and species level.

The use of this panel for the detection of SARS-CoV-2 virus is endorsed by the National Institute of Health (INS), according to the guidelines of the Ministry of Health and Social Protection of the country.

2. It has an overall sensitivity and specificity of 97.6% and 99.8% for RT-PCR.

3. Provides results in less than two (2) hours.

4. The required sample is easy to collect: nasopharyngeal swab taken by one of our bacteriologists, in any of our offices or at home.

NOTE: If you have respiratory symptoms or symptoms suggestive of COVID-19, we recommend that you request the home sampling service:

5. SARS-CoV-2 screening test (COVID-19) valid for domestic and international travelers, taking into account the required validity according to the country of destination. Delivery of result in English, if required. 

6. Consultation of electronic results through our Web portal or delivery of printed results in any of our offices.

alt="bacteriólogo domicilio"
** In conclusion, the use of multiplex panel-type diagnostic tests such as the BiofireⓇ FilmArrayⓇ allows the timely and certain establishment of the pathogens most commonly implicated in respiratory infections, supports medical personnel in the timely definition of pharmacological treatments and clinical-epidemiological behaviors necessary for the rapid rehabilitation of patients, while preventing the spread of infections to others and controlling ongoing outbreaks. This translates into a reduction of health care costs due to unnecessary admissions and treatments (e.g. reduction of hospital stay), reduction of antibiotic resistance due to unnecessary prescription and use (e.g. use of drugs with no clinical utility in viral infections), and rational and efficient use of health care resources.


Nos gustaría conocer tu opinión sobre la experiencia que viviste con nuestros servicios.


1. ¿Cómo evalúas tu experiencia con los servicios prestados por el Laboratorio Clínico Hematológico?

Donde 1 es la más baja calificación y 5 la más alta.
Donde 1 es la más baja calificación y 5 la más alta.
Donde 1 es la más baja calificación y 5 la más alta.
Donde 1 es la más baja calificación y 5 la más alta.
Donde 1 es la más baja calificación y 5 la más alta.
2. ¿Cómo calificaría su experiencia global respecto a los servicios de salud que recibió en el Laboratorio?
3. ¿Recomendaría a sus familiares y amigos los servicios del Laboratorio?

Déjanos tu nombre completo, celular y correo electrónico (Opcional)