SOP â Malaria Microscopy - NVBDCP

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Quality Assurance of Malaria Diagnostic testsGLOSSARYQuality is defined as a set of processes/ procedures which ensure that whateverfunction/assay is undertaken produces an outcome/result/product which is valid, accurate,reliable, reproducible and has met all the quality standards laid down for the saidfunction/assay.Competency in microscopy, competence is the skill of a LT for performing an accurateexamination and reporting of a malaria blood film.External Quality Assessment (EQAS) involves specimens, of known but undisclosedcontent being introduced into the laboratory by designated “Apex/Reference“ laboratory andexamined by the staff of participating laboratory/ies using the same procedures as used forroutine/normal specimens of the same type. This method checks the accuracy of the testresults produced by the participating laboratories.Internal audit is the process of critical review of all the functions of the laboratory toestablish whether all activities that ensure quality are being carried out. Internal audits arealso called first party audits i.e. those audits which are performed by the staff of laboratoriesthemselves to inspect their own system.Internal Quality Control (IQC) describes all the activities taken by a laboratory to monitoreach stage of a test procedure to ensure that tests are performed correctly, that is accuratelyand precisely.Negative Predictive Value (NPV) is the probability that the disease is absent when the testis negative. The lower the prevalence, the greater the likelihood of high NPV.Prior Probability or Prevalence is the probability of the disease before the test is carriedout that a subject has the disease.Performance of Laboratory Technician is the accuracy of a LT examining malaria slides inroutine practice. For assessment of the performance of a LT setting standards ofperformance is a prequisite.Positive Predictive Value (PPV) is the probability that the disease is present when the testis positive, the higher prevalence the higher PPV since there exists lower probabilities offalse positive results in a populations where there are few true negatives.Quality Assurance is a wide ranging concept covering all components that individually orcollectively influence the quality of a product. It is the totality of the arrangements made withthe objective of ensuring that the product is of the required quality for its intended use. Itdenotes a system for continuously improving reliability efficiency and utilization of productsand services.Quality Control (QC) describes all the activities taken by a laboratory to monitor each stageof a test procedure to ensure that the tests are performed correctly and results produced areaccurate and precise. QC must be practical, achievable and affordable.SOP – Malaria Microscopy© Copyright to Dte. NVBDCP Only. Any modification are prohibited
Quality Assurance of Malaria Diagnostic testsStandard Operating Procedures (SOP) are the most important documents in a laboratory.These describe in detail the complete procedures for performing tests and ensures thatconsistent and reproducible results are generated.Sensitivity is the probability that it will produce a true positive result when used in aninfected population (as compared to a reference or “gold standard”)A highly sensitive test detects all the individuals who are infected but may also detect aspositive few individuals who are not infected.Specificity is the probability that it will produce a true negative result when used on a noninfected population (as determined by a reference or “gold standard”)A highly specific test correctly identifies all the individuals who are not infected as negative,but may detect few infected cases (early infection, low parasiteamia cases) also as negative.SOP – Malaria Microscopy© Copyright to Dte. NVBDCP Only. Any modification are prohibited
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Reporting form for QA of microscopy
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SOP â Malaria Microscopy - NVBDCP

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SOP â Malaria Microscopy - NVBDCP