Common Terminology

Common terminology used by the EQA provider.

EQA panel: a panel consists of 4 DCS

DCS: a single dried culture spot

GeneXpert instrument: a GeneXpert instrument can consists of 1 or more modules that are connected to a single computer. 1 EQA panel is designed for 1 instrument.

GT-Blot 48: A fully automated system for hybridization of the GenoType product series.

TwinCubator: Manual hybridization platform for processing products based on DNA strip Technology.

csv: Comma separated value (default setting when you export your results from a GeneXpert instrument).

IR: Investigation report.

Export: The process of creating a csv file that contains ONLY the EQA results OR ONLY the Verification results to upload onto the suitable Result Reporting Tool.

Upload: process of submitting your EQA or Verification results to SmartSpot Quality using SmartSpots test specific Result Reporting Tool.

www.tbgxmonitor.com the web-based Result Reporting Tool for Xpert TB EQA and Verification

www.lpamonitor.com the web-based Result Reporting Tool for Genotype LPA EQA

www.viralloadmonitor.com the web-based Result Reporting Tool for Xpert, ABBOTT and Roche HIV EQA and Verification

www.tbgxmonitor.com

Frequently asked questions:

DCS panel receipt.

Q: If more than 1 EQA panel is received in a shipment (at one time), should all the panels be tested at once?

A: No, please check the package labels for the submission deadline of each panel. Only the panel due for submission should be tested and the other panels stored until their submission time. Please DO NOT MIX THE DCS between panels.

Q: Should all 4 DCS of an EQA panel be tested if the site only has a Gx4-1L (1 module instrument) or Gx4-2L (2 module instrument)?

A: YES, all 4 DCS in 1 EQA panel must be tested and results submitted on the appropriate online result reporting tool.

Q: If the instrument has more than 4 modules, which modules should be used to test the DCS?

A: Please log on to tbgxmonitor.com; lpamonitor.com or viralloadmonitor.com (using the lab credentials) prior to testing the DCS. Scroll down to the bottom of the Home page to check which modules are recommended for testing in that particular EQA submission round.

Q: If one of the GeneXpert modules are not functional, can all 4 DCS still be tested?

A: Yes, all 4 DCS must still be tested on the remaining functional modules.

Q: If all 4 the DCS were tested on the same module, can the results still be uploaded and scored?

A: Yes, the results are calculated independent of the module the DCS are tested on.

DCS testing process:

Q: Why is vortexing the DCS in the SR buffer important?

A: The inactivated bacteria are dried on the cotton DCS, and vortexing the DCS in the SR buffer will aid in resuspending the bacteria in the buffer in order to add the solution to the Xpert cartridge for testing.

Q: How can the disintegration of DCS in the SR buffer be prevented?

A: Once the SR buffer is added to the tube containing the DCS, vortex the tube (or shake vigorously) for only 5 seconds at a time and allow to stand at room temperature for the time allocated in the SOP. ONLY perform this step TWICE.

Q: If the DCS does break up (disintegrate), can the specimen still be tested?

A: The cotton threads can break apart and may clog in the Xpert cartridge. This could cause an error on the instrument whilst running the assay to test this specimen. If the DCS does disintegrate, carefully pipette off the liquid to be added to the cartridge and ensure that no disintegrated particles are transferred to the Xpert cartridge.

Q: Is a replacement DCS required in the case of an error or invalid result?

A: No, a replacement DCS is not required for an instrument error, please upload all the results (including the error/invalid). Verification of the module is recommended (please see Verification section, under Products).

Q: Can the DCS barcode be scanned as a patient ID or a sample ID?

A: Please scan or enter the DCS barcode as the Sample ID.

Submitting Xpert EQA results:

Q: How are the results submitted onto the Result Reporting Tools?

A: All four the results of an EQA panel must be exported from the GeneXpert instrument (according to the instructions on the SOP) in a single .csv file. The results are uploaded by logging into the result reporting tool, using the provided lab credentials and performing a New Submission.

Q: Can an invalid or error result be uploaded?

A: Yes, please ensure that all 4 DCS of an EQA panels results are exported in a single .csv file and uploaded onto the online result reporting tool.

Q: Can the EQA results be uploaded any time before the submission deadline?

A: Each panel has a specified submission deadline. Result submission for each phase opens 1 month prior to the submission deadline. PLEASE DO NOT WAIT UNTIL THE LAST DAY TO SUBMIT RESULTS AS THE ONLINE RESULT REPORTING TOOL MAY CAUSE DELAYS.

Q: What happens if the results cannot be submitted by the submission deadline?

A: Please contact info@SmartSpotQ.com for assistance in the event of experiencing any difficulty in uploading results.

Feedback from EQA provider:

Q: How soon will a report be released after submitting results?

A: If the site has achieved a full score (100%), the result report will be automatically released and available for download on tbgxmonitor.com. If the site did not achieve 100%, the report will be reviewed by the EQA provider and released within ~7 days post submission deadline.

Q: What is an IR process?

A: The IR is an Investigation Report, completed by a site that did not achieve a full score (100%). This form can be found on the Online Result Reporting Tool under the Feedback tab and will assist the site in determining why a full score was not achieved.