Topic - Virology
Q. Discuss the quality control of serological assays at least in 100 words.
Answers
1. The condition of the specimens - the specimen should be clearly labeled with patient details using at least two different identifiers. the specimen to be tested should not be haemolysed or lipaemic. Utmost care must be taken during the splitting of the specimen so that the correct specimen is placed into the correctly labeled tube.
2. The educational background and training of the laboratory personnel. A continuing education program for laboratory workers should be included and individual laboratory personnel should be evaluated to identify areas for improvement
3. The controls used in the test runs - appropriate internal and possibly external controls should be used in each test run.
4. Up to date performance records of each test run and quality control procedures should be kept.
5. The interpretation of results - results should be interpreted according to the manufacturer's criteria. Where the interpretation of the test is potentially subjective, as in the case of haemagglutination-inhibition, complement-fixation, or single-radial haemolysis, it may be advisable for the results to be read and counterchecked by a second person.
6. The transcription of results - Transcriptional or clerical errors include mistakes made during the transfer of information from the test readout to the worksheet, and from the worksheet to the computer or report form. These type of errors probably account for the majority of errors in the laboratory. Possible mechanisms include having a second technologist to check the final result and the supervisor to check the results before releasing.
7. The reporting of results - the results should be reported in a timely manner to the appropriate individual. The report should be authorized by a suitably qualified individual.
8. Internal audit - regular audits should be carried out to look at the quality assurance program.
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