Test Code (รหัสการทดสอบ):
Order set: RP3 Plus
Order Name (ชื่อการทดสอบ):
Respiratory Pathogens (RP3) Plus: Influenza A&B/ SARS-CoV-2 and other Respiratory Pathogens, RT-PCR
Clinical Information (ข้อมูลทางคลินิก):
Respiratory pathogens cause acute local and systemic illnesses that range in severity, and have the potential to cause severe disease especially in the young and elderly and immunocompromised individuals. Respiratory symptoms can include coughing, nasal discharge, congestion, fever, wheezing, shortness of breath, headache, and myalgia. Due to the similarity of diseases caused by many viruses and bacteria, diagnosis based on clinical symptoms alone is difficult. Identification of potential causative agents provides data to aid the physician in determining appropriate patient treatment and public health response for disease containment.
The BioFire RP2.1 is a real-time, nested multiplexed polymerase chain reaction test designed to simultaneously identify nucleic acids from 22 different viruses and bacteria associated with respiratory tract infection from a single nasopharyngeal swab (NPS) specimen.
Reference Value (ค่าอ้างอิง):
Not detected
Interpretation (การแปลผล):
1. Results from this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
2. The BioFire RP2.1 is a qualitative test and does not provide a quantitative value for the organism(s) in the specimen.
3. The performance of the BioFire RP2.1 has not been established for monitoring treatment of infection with any of the panel organisms.
4. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
5. A negative BioFire RP2.1 result does not exclude the possibility of viral or bacterial infection. Negative test results may occur due to the presence of sequence variants (or mutation) in the region targeted by the assay, the presence of inhibitors, an infection caused by an organism not detected by the panel, or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Test results may also be affected by concurrent antiviral/antibacterial therapy or levels of organism in the specimen that are below the limit of detection for the test. Negative results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
6. Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms.
7. The BioFire RP2.1 influenza A virus subtyping assays target the influenza A virus hemagglutinin (H) gene only. The BioFire RP2.1 does not detect or differentiate the influenza A virus neuraminidase (N) subtypes.
8. Recent administration of nasal vaccines (e.g. FluMist) prior to NPS specimen collection could lead to accurate virus detection by the BioFire RP2.1 of the viruses contained in the vaccine but would not represent infection by those agents.
9. Due to the genetic similarity between Human rhinovirus and enterovirus, the BioFire RP2.1 cannot reliably differentiate them. A BioFire RP2.1 rhinovirus/enterovirus Detected result should be followed up using an alternate method (e.g. cell culture or sequence analysis) if differentiation between the viruses is required.
10. Primers for both BioFire RP2.1 SARS-CoV-2 assays share substantial sequence homology with the Bat coronavirus RaTG13 (accession: MN996532) and cross-reactivity with this closely related viral sequence is predicted. In addition, the SARSCoV2-2 assay may cross-react with Pangolin coronavirus (accession: MT084071) and two other bat SARS-like coronavirus sequences (accession MG772933 and MG772934).
Clinical Reference (เอกสารอ้างอิง):
Manufacturer’s package inserts. BioFire® Respiratory Panel 2.1 (RP2.1), September 2023, BioFire Diagnostics, Salt Lake City, UT 84108, USA.