Data of Manufactured Panel Test Smears In The Who–Rntcp, Gujarat, India

Dr. Nilesh D. Patel; Dr. Paresh V. Dave; Dr. Kiran Rade

Volume : III, Issue : X, October - 2014

Data of Manufactured Panel Test Smears In The Who–Rntcp, Gujarat, India

Dr. Nilesh D. Patel, Dr. Paresh V. Dave, Dr. Kiran Rade

Abstract :

Aim: To present an overview of manufacturing and validation data about proficiency panel test smears in the RNTCP–EQA, India guideline. Material and Methods: The Intermediate Reference Laboratory, Ahmedabad; Gujarat state, India is a well–functioning tuberculosis reference laboratory and has clinical laboratory resources and instruments required for manufacturing and validating proficiency panel test slides. Manufacturing and validating proficiency panel test smears is an important integral part of EQA guideline, and the Intermediate Reference Laboratory; Ahmedabad is implementing it since 2005, an overview of which is presented in this article. All tuberculosis laboratory procedures described here had been performed in biological safety cabinets along with universal safety precautions as per the WHO–RNTCP guidelines. Results: For each panel batch, it took two to three weeks for abiding manufacturing and validation procedure. The smear characteristics were pleasingly different from those of routine Z–N smear. Four to six intermediate reference laboratory personnel validated consistency of each batch of slides by selecting a sample of six slides from each AFB grade, staining and reading it. True consistency level was found for each AFB grade in every validated batch. Conclusion: Manufacturing panel slides requires considerable resources like well–equipped laboratory, dedicated laboratory staff and meticulous documentation of validation process. Inclusion of N–acetyl–L–cysteine is a key part of sputum digestion process. The technical quality of smears manufactured at the Intermediate Reference Laboratory, Ahmedabad was satisfactory. With this labour intensive and time consuming process, EQA has come closer to gold standard Z–N smear, at least in proficiency panel testing if not in re–checking mechanism. Validated panel smears can be successfully used for assessing proficiency of the laboratory staff in sputum smear microscopy