Auroprobe Laboratories' quality system begins right from the inception. The Molecular Diagnostic Facility is designed and constructed according to international standards with introduction of Class 100 Clean Rooms for the first time in the Indian Diagnostic Industry.

A special Quality Assurance Unit is established to strategize, plan, implement and monitor all quality assurance protocols. All the Laboratory activities are strictly conducted in conformity with the systems and procedures based on ISO 9001:2000 Quality Management System. Auroprobe Laboratories has instituted many physical and procedural safeguards to prevent contamination problems in its molecular diagnostic facility.

Physical Safeguards

	Auroprobe's PCR facility is designed as four distinct areas. One for receiving and sorting samples, second for reagent preparation, third for DNA extraction and PCR setup and fourth for amplification and image analysis of PCR products
	Each area has its own ventilation system which maintains 100% air exchange with outside air and no exchange between rooms
	Two clean rooms of class 100 (100 times more sterile than an operation theatre) are specially designed for PCR diagnostic tests, with controlled air pressures through air handling units, High Efficiency Particulate Air (HEPA) filters and laminar flow benches. Maintenance protocols meeting international standards are followed stringently to establish the clean room conditions
	To completely avoid false positive results the area are designed so that individuals entering and leaving must go through three-door airlock systems
	Equipped with state-of-the-art automated instrumentation to ensure uniformity of test results

	Specially trained technical personnel and specific procedure protocols to avoid contamination e.g. gentle uncapping, use of aerosol barrier tips and positive displacement pipettes etc.
	Laboratory personnel are separated by task in order to avoid personnel mediated carry-over of amplified material from area to area
	Showering and sterile surgical gowning before entering clean rooms for PCR reagent set-up & DNA extraction
	False negative results are avoided by collection in ACD Vacutainer, storage and transportation at 40C, and use of special columns to remove substances such as heme, proteins & phosphates which are present in the sample and may inhibit the PCR reaction
	In enzyme based amplification processes, such as PCR, efficiency can be reduced by inhibitors that may be present in the clinical specimen. The Internal Control is used in the reaction master mix to identify the processed specimens containing substances that may interfere with PCR amplification
	The selective amplification of target nucleic acid from the clinical specimen is achieved by the use of Uracil-N-glycosylase (UNG) and deoxyuridine triphosphate. Uracil-N-glycosylase (UNG) recognizes and catalyzes the destruction of DNA strands containing deoxyuridine, but not DNA containing thymidine. Deoxyuridine is not present in naturally occurring DNA, but is always present in amplicons due to the use of deoxyuridine triphosphate as one of the dNTPs in the Master Mix Reagent; therefore, only amplicons containing deoxyuridine get degraded by UNG
	The facilities are irradiated with UV lights to create thymidine dimers in amplicons, so that in case they do contaminate the reaction mixture, they cannot act as template for further amplification