16S Gene Sequencing (Mycobacterial organism identification - SeqStudio)

Identification of mycobacterial organisms by 16S gene sequencing on the SeqStudio analyzer.

Storage and Transport Criteria: Specimen Storage Specimen Transport

Acceptable Specimens

Minimum Volume

Frozen Range
-70°C - 0°C

Refrigerated Range
0.1°C - 8°C

Room Temperature Range
8.1°C - 30°C

Stability at
4°C - 25°C

Pure culture isolate N/A Reject Acceptable Acceptable 8 hours
Includes: Identification of mycobacterial organisms by 16S gene sequencing on the SeqStudio analyzer.
Methodology: Sanger sequencing
Assay Category: LDT (Laboratory Developed Test)
Reference Range: See laboratory report
Alternative Names: AFB identification
Preferred Specimen(s): Pure culture isolate
Alternative Specimen(s): N/A
Minimum Volume: N/A
Special Instructions: Order Mycobacteria - Smear and Culture for primary specimens.
Reject Criteria: Swab specimens

Inadequately labeled specimens

Leaking specimens

QNS (quantities not sufficient)

Specimens not meeting the Storage & Transport criteria upon receipt at laboratory
Setup Schedule: Testing is performed on an as-needed basis.
Turn around time (TAT): 8 weeks from arrival at the lab.

Acceptable Specimens	Minimum Volume	Frozen Range -70°C - 0°C	Refrigerated Range 0.1°C - 8°C	Room Temperature Range 8.1°C - 30°C	Stability at 4°C - 25°C
		Specimen Storage			Specimen Transport
Pure culture isolate	N/A	Reject	Acceptable	Acceptable	8 hours