ACTA NEUROPHARMACOLOGICA ›› 2022, Vol. 12 ›› Issue (2): 14-.DOI: 10.3969/j.issn.2095-1396.2022.02.003

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Internal Quality Control and External Quality Assessment of SAT Test for Mycoplasma Pneumoniae

WANG Bin,XU Jia-yin,LI Ya-di,et al   

  1. 1. The Department of Pharmacy,Hebei North University,Zhangjiakou,075000,China  2. Hebei Key Laboratory of Neuropharmacology,Hebei North University,Zhangjiakou,075000,China  3. Jianyuan Precision Medicine (Zhangjiakou) Co.,Ltd. Zhangjiakou,075000,China  4. The Department of Journal Editorial,Hebei North University,Zhangjiakou,075000,China
  • Online:2022-04-26 Published:2022-04-26

Abstract:

Objective:The method of testing Mycoplasma pneumoniae by SAT was used to carry out Internal Quality Control and External Quality Assessment in Zhangjiakou Jianyuan Medical Laboratory,so as to find out the deficiencies of the laboratory and make adjustments to improve the laboratory quality. Methods:Mycoplasma pneumoniae (MP) quality control products were diluted 10 times as positive control,and then diluted 10 times,100 times and 1 000 times on the basis of the positive control,in which the dilution of 100 times and 1 000 times was repeated for four times. Simultaneous Amplification and Testing (SAT) of RNA was used to observe the curve,sensitivity and precision of detection under the same conditions as negative control and positive control. In addition,multiple MP samples provided by the Molecular Laboratory of the Pediatric Research Institute of Tianjin Children’s Hospital were carried out blind RNA testing. Finally,the test results of the two laboratories were compared to make an accurate evaluation of the laboratory. Results:The quality control products with 10 times,100 times and 1 000 times dilution were all positive,and the CT values were all less than 30 cycles. Observe the curves of four repeat tubes of 100 times diluted quality control products and the curves of four repeat tubes of 1 000 times diluted quality control products,all of which are “S” shaped curves. The results of MP sample RNA blind test were positive for the first one and negative for the rest,which were consistent with the results provided by the Molecular Laboratory of Pediatric Research Institute of Tianjin Children’s Hospital. Conclusion:IQC test shows that the laboratory has good sensitivity and precision,and EQA test shows that the laboratory has very high accuracy,which all meet the requirements of relevant standards for the laboratory,making the test results more meaningful.

Key words: internal quality control, external quality assessment, myocoplasima pneumonia, simultaneous amplification and testing

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