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| UWHC Lab Test Details | |
|---|---|
| Test Name | Bacterial Identification by 16S |
| Test Code(s) | HCBID16S |
| CPT Code(s) | 87153 |
| Methodology | PCR followed by Direct Sequencing |
| Clinical Information | The 16S rRNA gene is a short section (~1500 basepairs) of prokaryotic DNA found in all bacteria and archaea. The 16S rRNA gene is a commonly used tool for identifying bacteria because analysis of an organism's DNA is often more definitive than classification based solely on phenotypic characteristics. |
| Days Performed | Mon and Thurs. |
| In-Lab Turnaround Time | 5 days. |
| Stat In-Lab Turnaround Time | 2 - 3 days. |
| Collection Requirements | |
|---|---|
| Collection Instructions | Whole Blood - (EDTA tube, drawn with blood culture collection technique to avoid contamination)- min. of 250 uL. Refrigerate. Bone Marrow - (EDTA tube) - min. 250uL. Refrigerate Body Fluid from sterile sites- min. of 250 uL in a sterile container. Refrigerate. CSF- min. of 250 uL in a sterile container. Refrigerate. Pleural Fluid- min. of 250 uL in a sterile container. Refrigerate. Peritoneal Fluid- min. of 250 uL in a sterile container. Refrigerate. Synovial Fluid- min. of 250 uL in a sterile container. Refrigerate. Deep Tissue- sterile container. Refrigerate. |
| Specimen Processing Requirements | |
|---|---|
| Testing Volume | 0.2 mL |
| Pediatric Testing Volume | 0.2 mL |
| Specimen Processing | The laboratory routinely pools multiple like specimens. If multiple like specimens are received, provider must indicate if pooling of specimens is NOT desired. Cultures must be performed and no growth observed after two days of incubation prior to ribosomal sequence analysis being performed on direct specimen. The two day incubation does not apply to specimens where there is strong clinical suspicion of a bacterial organism that will not grow in routine culture. |
| Unacceptable Criteria | Skin, mucosal surfaces, BAL, urine, feces and other sites containing normal bacterial flora are not suitable for 16S analysis. |
| Interpretation | |
|---|---|
A written interpretive report is provided by the laboratory | |
| Additional Information | Organisms are identified to a genus and species level, whenever possible, by aligning two PCR amplified regions of DNA sequence across the 16S ribosomal RNA gene against publicly available databases with generally > 99% agreement of the alignment being required for a definitive and acceptable bacterial identification to the species level. All real-time PCR and DNA sequencing data is reviewed for analytical quality. Bacterial identification by 16S rRNA DNA sequencing is correlated to phenotypic characteristics, when available, from the UWHC Clinical Microbiology Laboratory and is assessed in the context of the overall clinical presentation of the patient.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
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