Technical SupportSeptember 20, 2024·2 min read

Chemiluminescence Immunoassay Reagent Selection and Quality Control

A professional analysis of the key points in chemiluminescence immunoassay reagent selection and of quality control measures, helping laboratories improve testing quality.

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Technical Support Team

Published September 20, 2024

Chemiluminescence Immunoassay Reagent Selection and Quality Control

Chemiluminescence immunoassay (CLIA) has become a mainstream technology for clinical immunoassay testing thanks to its high sensitivity, wide linear range and other advantages. This article offers a professional analysis of the key points of reagent selection and quality control.

Key Points of Reagent Selection

Performance Indicators

When selecting chemiluminescence reagents, attention should be paid to the following performance indicators:

| Parameter | Requirement |

|------|------|

| Sensitivity | Low detection limit; can detect low-concentration samples |

| Specificity | Low cross-reactivity rate |

| Precision | Within-lot CV <10%; between-lot CV <15% |

| Linear range | Covers clinical testing needs |

Compatibility Considerations

Xinke Medical's chemiluminescence reagent product line covers a variety of analyzer platforms:

  • Abbott series: compatible reagents for the Architect and Alinity platforms
  • Beckman series: compatible reagents for the Access and Dxi platforms
  • Roche series: compatible reagents for the Cobas platform
  • Cost-Effectiveness Analysis

    When choosing reagents, besides performance indicators, a cost-effectiveness analysis is also needed:

  • cost per test
  • reagent stability (open-vial stability)
  • calibration frequency
  • maintenance costs
  • Quality Control Measures

    Internal Quality Control

  • establish a comprehensive quality control system
  • use third-party quality control materials
  • carry out regular precision verification
  • External Quality Assessment

  • participate in the external quality assessment organized by the National Center for Clinical Laboratories of the Ministry of Health
  • compare and analyze deviations in results
  • continuously improve testing quality
  • Technical Support

    Xinke Medical provides full-range technical support services, including reagent selection consultation and quality control guidance. If you have any needs, please feel free to contact the technical support team.


    Chemiluminescence Immunoassay Reagent Selection and Quality Control | Xinke Medical