Bacteria – 16S rDNA Test

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Testing Indications

This test is intended to be used on clinical specimens from normally sterile sites in which bacterial infection is suspected however all routine culture methods (or specific molecular panels) have been negative. 16S rDNA testing on culture negative clinical samples requires approval from PHOL customer service centre before sample can to be submitted to lab. This is not a STAT test.

Specimen Collection and Handling

Specimen Requirements

Test Requested	Required Requisition(s)	Specimen Type	Minimum Volume	Collection Kit
16S rDNA	General Test Requisition	Tissue	0.5 grams	Sterile container Virus-Enteric kit Order # 390087
16S rDNA	General Test Requisition	CSF	250 ul	Sterile container Virus-Enteric kit Order # 390087
16S rDNA	General Test Requisition	Aspirate	500 ul	Sterile container Virus-Enteric kit Order # 390087
16S rDNA	General Test Requisition	Body fluids	500 ul	Sterile container Virus-Enteric kit Order # 390087
16S rDNA	General Test Requisition	Swabs	500 ul	Virus Respirarory Collection kit. Order number 390082

Submission and Collection Notes

This is not a STAT test. Call PHOL CSC- customer service centre at 1-877-604-4567/416-235-6556, Monday to Friday 8 am to 5 pm EST to obtain approval before submitting a sample for 16s rDNA testing. Provide information regarding sample type, clinical history, any other testing performed.

Specimens types not listed above (eg. fixed tissue, blood samples) must be discussed with the Microbiologist

Limitations

This is not a STAT test.

Failure to detect bacterial 16S rDNA does not rule-out the possibility of bacterial infection.

Samples with multiple species of bacteria present may be uninterpretable.

Identification of bacterial DNA from one species does not eliminate the possibility of DNA from other species being present in the sample (typically in lower amounts that may go undetected).
Test results must be correlated with patient’s clinical presentation, treatment history and other findings.

This is an laboratory-developed end-point PCR and Sanger sequencing based assay that has not been Health Canada cleared or approved.

Storage and Transport

Label the specimen container with the patient’s full name, date of collection and one other unique identifier such as the patient’s date of birth or Health Card Number. Failure to provide this information may result in rejection or testing delay.

Special Instructions

Specimens should be stored at 2-8°C following collection and shipped to PHOL on ice packs.

Requisitions and Kit Ordering

Test Frequency and Turnaround Time (TAT)

16S rDNA testing is performed twice a week. TAT is up to 3-5 days from the time of receipt at PHO Laboratory.

Test Methods

16S rDNA testing is end point PCR test followed by Sangar sequencing, if an amplicon of the correct size is observed after the PCR step.

Reporting

Detected results are called out the the ordering physician or health care provider if provided on the requisition or on the CSC 16S notification.

Final results of 16S rDNA testing from PHO Laboratory are reported to the ordering healthcare provider as indicated on the requisition.