Comparison of impact of original reagents vs third party hematology reagents on patient reports

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Dr. Neeraj Jain1, Dr. Arvinder Singh2, Shubham Rastogi3, Ajay Sajwan4
1MD (Pathology), Chief Pathologist at Jain Lab, Delhi, India, 2MD (Pathology), CEO & Chief Pathologists, Arth Diagnostics, Udaipur, Rajasthan, India, 3Marketing Consultant, HORIBA, India 4Consultant, HORIBA, India

Abstract

Analysis of patient’s blood samples and providing accurate result is very important for a medical laboratory. It has been observed that nowadays many third-party reagent manufacturers have started providing reagents in competition with original equipment manufacturer. This study is meant to evaluate third-party reagents in terms of quality and impact on patient results and impact on analyzer in comparison to reagents supplied by original equipment manufacturers.

This study is conducted on the ABX Micros 60 analyzer from HORIBA Medical, Japan at Jain’s diagnostic laboratory, New Delhi. Third-party reagents of different companies who claim the compatible reagents for ABX Micros 60 were analyzed in comparison to HORIBA original reagents. The comparison was made on patient blood samples for Complete Blood Count (CBC) parameters and microbiology tests.

The study depicts that third-party reagents are inferior because they show bacterial and fungal contamination, leads to false flags and alarms and substandard patient CBC parameter reporting. Although the cost of the third-party reagents is lesser than the original certified reagents of the company leading to cost saving for the clinical laboratory but results in compromise in quality of patient report as well as long term damage to instruments and increased maintenance cost. We advise laboratory to use reagents of Original Equipment Manufacturer (OEM) to ensure better and consistent quality.

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