Ordering Information

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

 

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.

Test Details
Specimen Type: Bronchoalveolar Lavage (BAL)
Collect: Collect BAL specimens in sterile containers
Specimen Preparation: Specimen Source Required
Transfer 2 mL to a sterile container. (Min: 1 mL)
Place specimen in an individually sealed biohazard bag
Specimen Type: Sputum
Collect: Have the patient rinse the mouth with water
Instruct the patient to take a deep breath and cough to obtain deep sputum and expectorate into sterile container
Repeat until the minimum amount of sample is obtained
Close the lid of the sterile container
It is important to obtain sputum (thick) and not saliva (clear)
Specimen Preparation: Specimen Source Required
Transfer 2 mL to a sterile container. (Min: 1 mL)
Place specimen in an individually sealed biohazard bag
Specimen Type: Nasopharyngeal Swab
Collect: Place the patient in a comfortable, sitting position with head tilted backwards
Use nasopharyngeal swab and insert through nares (parallel to the palate) to the back of the nasopharynx until meeting resistance
Gently rotate the swab for 20–30 seconds (or until inducing cough) while the swab is in contact with the nasopharynx to absorb secretions
Place the swab immediately in transport media
Specimen Preparation: Specimen Source Required
Transfer 2 mL to a sterile container. (Min: 1 mL)
Place specimen in an individually sealed biohazard bag
Specimen Type: Tracheal Aspirate
Collect: Collect Tracheal Aspirate specimens in sterile containers
Specimen Preparation: Specimen Source Required
Transfer 2 mL to a sterile container. (Min: 1 mL)
Place specimen in an individually sealed biohazard bag
Transport Temperature Specimen Stability Reject Criteria
Frozen Frozen: 30 days

Refrigerated: 4 days

Ambient: Unacceptable

Received at temperature other than frozen

1. Collect specimen as per your institutional protocols.

2. Complete the Test Requisition Form (TRF) online and print it, or complete the form included in the shipping kit and provide all REQUIRED INFORMATION.

3. Send specimen in a sterile tube (minimum volume: 2 mL). Aliquot the primary sample only when necessary and under sterile conditions into the provided specimen collection tube. Close the tube securely.

4. Label the sterile tube with patient name, DOB, sex, and your internal ID.

5. Place the specimen collection tube into the provided biohazard bag containing the absorbent sheet and seal the bag.

6. Place the completed TRF into the outside pouch of the sealed biohazard bag.

7. Place 2.0 kg of dry ice in box.

• Dry ice must completely surround the samples before sealing the package.

• If there is not enough room for the full 2.0 kg of dry ice, use an additional box for the overflow of samples.

This will require additional 2.0 kg of dry ice.

8. Close the styrofoam cooler (do not tape the lid closed).

9. Securely close the outer cardboard box using the adhesive strip on the box flap.

10. Indicate 2.0 kg of dry ice packaged in the box, in the space provided next to the dry ice label.

11. Affix the pre-filled FedEx label to the top of the outer box.

12. Ship box via FedEx.

*FedEx deliveries to IDbyDNA are currently possible Monday – Saturday. All specimen shipments should be scheduled Monday – Friday to avoid delays in shipping and receipt of thawed specimens.