Internal Quality Control Kits for Immunochromatographic Test SD Bioline Assay/Capillia/TBcID

A positive and a negative control must be tested with each new lot or a new shipment of kits received and with each new batch of extraction buffer prepared. Similarly, these controls must be run weekly or along with each batch of patient isolates when tests are set up less frequently.

1. Frequency:

• Each new lot or shipment of kits and each new prepared lot of extraction buffer. 

• Weekly, or with each batch of patient tests, if testing is performed less frequently.

2. Controls:

• Internal reagent control in the device

• Positive control: Culture of M. tuberculosis reference strain (H37Rv or H37Ra) in MGIT broth

• Negative control: Culture of a MOTT strain (e.g., a well-characterised strain of M. avium complex) in MGIT broth or broth from an uninoculated MGIT tube

3. Acceptable results: Correct results as expected for all controls

• The internal control line is visible. 

• M. tuberculosis must result in a positive test.

• MOTT strain or uninoculated broth must result in a negative test.

 4. Corrective actions: If any control result is unacceptable, do not report patient tests. 

• Repeat the test with new controls; if acceptable, repeat patient tests

• If repeat results are still unacceptable, notify the supervisor immediately and investigate potential causes for failure.

• After the investigation is complete and QC is acceptable, repeat patient tests and report results.

  Resource

   GLI Mycobacteriology Manual

1.   Assessment