Explify Respiratory

Test Overview

Overview
Explify Respiratory uses next-generation sequencing (NGS) to simultaneously identify more than 900 potential pathogens and other microorganisms, including viruses, bacteria, fungi, and parasites.

Interpretive Data
Explify Respiratory detects potentially pathogenic and commensal microorganisms by unbiased next-generation sequencing of viral, bacterial, fungal, and parasite transcriptome and genome sequences. Sequencing data are interpreted by the Explify software.

Microorganisms that are likely pathogens based on published studies are listed in the “Potential Pathogens” section of the report. Microorganisms for which the relevance to respiratory disease is less well established are listed under “Additional Microorganisms Detected”. This distinction is made to assist in result interpretation and may or may not be relevant for a given patient. Results need to be interpreted in conjunction with the clinical history, results of other laboratory tests, epidemiologic information, and other available data. If multiple microorganisms from a given class (e.g. bacteria) are detected, their relative abundance is calculated based on normalized sequencing read counts.

Inconclusive Results
Inconclusive results indicate questionable presence of potential pathogens and/or additional microorganisms. This may be due to very low abundance of the microorganism, borderline sequence identity with known strains, etc.

Invalid Results
Invalid results indicate negative pathogen detection results in combination with ‘Reduced Analytical Sensitivity’. In these samples, the presence of potential pathogens and additional microorganisms cannot be excluded.

Non-Validated Results
Non-validated findings refer to any detected viruses, bacteria, fungi, or parasites that were not validated as part of the test validation. Non-validated findings are reviewed by a medical director prior to reporting.

Explify Respiratory was developed and its performance characteristics determined by IDbyDNA Inc. Explify Respiratory has not been cleared or approved by the United States Food and Drug Administration (FDA). However, FDA clearance or approval is not currently required for laboratory-developed tests. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Test Limitations
Negative results do not rule out viral, bacterial, fungal, or parasite infections or the presence of potentially relevant microorganisms. If fungal infections are suspected, consider testing with fungal culture, the established reference method. Targeted, PCR-based tests are generally more sensitive and are preferred when specific pathogens are suspected, especially for mycobacteria, molds, and herpesviruses (CMV, EBV, HSV, VZV). Performance for detection of Mycobacterium tuberculosis was not evaluated; follow diagnostic guidelines. Stringent reporting thresholds are used for Escherichia coli and closely related Enterobacteriaceae due to their high genetic similarity, which may reduce analytical sensitivity for their detection. Low-positive results may not be reported. If Aspergillus is detected, only the most similar species will be reported, and the test does not report coinfections with multiple Aspergillus species.

The analytical sensitivity of this test depends on the cellularity of the sample and the concentration of all microbes present. Analytical sensitivity is assessed using internal controls that are added to each sample. Sequencing data for internal controls are quantified. Samples with internal control values below the validated minimum may have reduced analytical sensitivity or contain inhibitors and are reported as ‘Reduced Analytical Sensitivity’. Additional potential pathogens and additional microorganisms to those reported cannot be excluded in samples with ‘Reduced Analytical Sensitivity’.

Due to the complexity of next-generation sequencing methodologies, there may be a risk of false-positive results. Contamination with microorganisms from the oral cavity, upper respiratory tract, equipment, or the environment during specimen collection can also occur. The detection of viral, bacterial, fungal, and parasite nucleic acid does not imply organisms causing invasive infection. Viral, bacterial, fungal, and parasite nucleic acid may persist after microorganisms are no longer viable. Confirmation of positive results by an alternate method may be indicated in select cases.

Ordering Information
To inquire about ordering Explify Respiratory, please call IDbyDNA Client Services at: 833-397-5439 or email at clientservices@idbydna.com.