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Improving equivalence in fibrinogen evaluation between the prothrombin time-derived fibrinogen assay and Clauss method using a pooled plasma calibrator
  1. Sheng Wang1,
  2. Xiaoyong Duan2,
  3. Xingtai Liu1,
  4. Liuchun Wu3,
  5. Yan Zhang1,
  6. Xin Jin1
  1. 1 Department of Clinical Laboratory, Three Gorges University Third Clinical Medical College, Sinopharm Gezhouba Central Hospital, Yichang, China
  2. 2 Department of Emergency Medical, Three Gorges University Third Clinical Medical College, Sinopharm Gezhouba Central Hospital, Yichang, China
  3. 3 Department of Medical Business, Three Gorges University Third Clinical Medical College, Sinopharm Gezhouba Central Hospital, Yichang, China
  1. Correspondence to Dr Sheng Wang, Department of Clinical Laboratory, Three Gorges University Third Clinical Medical College, Sinopharm Gezhouba Central Hospital, Yichang 443002, China; 11423144{at}qq.com

Abstract

Aims Both the Clauss and prothrombin time-derived fibrinogen (PT-Fib) methods have widely been used in fibrinogen (Fib) evaluation. We aimed to improve the interchangeability between these two methods.

Methods Thirty fresh plasmas of low, normal and high Fib concentration were mixed to prepare the pooled human plasma. The Fib concentration was assessed by the Clauss method. The PT-Fib values were further recalibrated by the assigned plasma pools and the precision, linearity and reference intervals were verified according to the guidelines of American Society for Clinical and Laboratory Standards (CLSI) EP15-A and EP6-A documents. Finally, the recalibrated PT-Fib method was compared with Clauss method by the simultaneous Fib test of total 5259 coagulation samples.

Results The results indicated that the recalibrated PT-Fib method can detect the Fib concentration with clinically acceptable third-order linearity in the range of 1.27–8.00 g/L. Only one result out of 39 healthy people tested using the recalibrated PT-Fib method did not fall within the reference range defined by the manufacturer. We also found more than 99% of results between these two methods were interchangeable in the range of 1.51–8.00 g/L. The disagreement between these two methods was found only in patients with certain underlying conditions.

Conclusions After recalibration, the consistency between the PT-Fib and Clauss methods was enhanced and the interchangeability was improved. The application of the recalibrated PT-Fib method provided accurate and reliable results with the manufacturer-provided reagents and improved detection speed and cost-effectiveness.

  • fibrinogen
  • methods
  • chemistry
  • clinical
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Footnotes

  • Handling editor Mary Frances McMullin.

  • Contributors SW, XD and XJ conceived and designed research. SW, XD and XL collected data and conducted research. SW, LW, YZ and XJ analysed and interpreted data. SW wrote the initial paper. SW, XD and XL revised the paper. SW had primary responsibility for final content. All authors read and approved the final manuscript.

  • Funding This study was supported by 2019 Three Gorges University Youth Science Foundation Project (No. KJ2019A004).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. The datasets generated and analysed during the present study are available from the corresponding author on reasonable request.

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