CBNAAT Instrument Installation Criteria

It is important to adhere to the manufacturer's installation guide for optimal performance of the Cartridge-based Nucleic Acid Amplification Test (CBNAAT) machine. This guide should be kept in the laboratory. It is important to thoroughly read the instalment steps given in the brochure supplied with the machine.

Strict monitoring of these criteria should be carried out by the laboratory personnel:

• The instrument should not be kept directly under an air-conditioning vent or window. Direct sunlight should also be avoided.​
• The instrument's room should have temperature control (15-30°C).
• The instrument needs to be installed on a vibration free/ stable workbench with no centrifuge adjacent to it.
• There is a need for a stable electricity supply (for added safety, the instrument must be connected to an Uninterruptible Power Supply (UPS) or surge protector).

For safety purposes, one needs to provide 10 - 15 cm of clearance on each side of the instrument. 

Compliance with equipment installation criteria is necessary. The Instrument Qualification Documents include:

1. Installation Qualification - IQ
2. Operational Qualification - OQ
3. Performance Qualification - PQ

Installation Qualification

IQ provides evidence for the delivery, installation and configuration of the instrument as per the manufacturer’s standards using an installation checklist.

Operational Qualification

OQ is a collection of test cases used to verify the proper functioning of a system before the instrument is released for use.

Performance Qualification

PQ is a collection of test cases used to verify that the system performs as expected under simulated real-world conditions.

Video : CBNAAT Instrument Installation Criteria

Resources

• GeneXpert Package Insert