Consistency of abnormal results before and after re-determinations based on K+,Na+ and total calcium determinations

doi:10.3969/j.issn.1673-8640.2021.08.013

Abstract

Abstract:

Objective To investigate the consistency and acceptability of abnormal results before and afterre-determinations in clinical laboratory based on K⁺,Na⁺ and total calcium determinations. Methods The samples of abnormal K⁺,Na⁺ and total calcium concentrations close to clinically significant and critical levels were collected to evaluate the within-run and between-run coefficient of variation（CV）. According to the Clinical and Laboratory Standards Institute（CLSI） EP9-A3,the correlation between abnormal results before and after re-determinations was evaluated,and the deviation of results in clinically significant and critical levels was subsequently analyzed. Based on the methods aforementioned,the differences of abnormal K⁺,Na⁺ and total calcium levels before and after re-determinations were further assessed from January to June 2019. Results The CV of K ⁺,Na⁺ and total calcium concentrations close to clinically significant and critical levels were less than the allowable CV in WS/T 403—2012,the health industry standard of the People's Republic of China. The medically determined levels and critical values of K ⁺,Na⁺ and total calcium were respectively substituted into the linear equations obtained from the results before and after re-determinations to calculate the deviation,and the acceptable deviation was less than 1/3 of the allowable total error（TEa） of the Clinical Laboratory Improvement Amendment of 1988（CLIA'88）. In all the samples with abnormal results,the percentages of <1/3TEa-deviations were 99.6%,85.7% and 84.1% for K⁺,Na⁺ and total calcium concentrations,respectively. The percentages of >1/3TEa-deviations were 0.4%,14.3% and 15.9%,respectively. Conclusions Although the performance of the modern determination system is excellent,there is always some inevitably unacceptable results with high deviations. Therefore,the abnormal results in clinical determinations should be re-determined to ensure the accuracy of results before reporting,and to avoid unnecessary troubles caused by abnormal results affecting clinical decisions.

Key words: Consistency, Clinically significant level, Critical level, Allowable total error, Re-determination

CLC Number:

R446.1

LÜ Xianmin, YU Guoqi, CHEN Zhengzheng, JIANG Lihua, YAN Luwei, FEI Xianming. Consistency of abnormal results before and after re-determinations based on K⁺,Na⁺ and total calcium determinations[J]. Laboratory Medicine, 2021, 36(8): 843-846.

项目	批内			批间
项目	x/（mmol/L）	s/（mmol/L）	CV/%	x/（mmol/L）	s/（mmol/L）	CV/%
钾/（mmol/L）
2.80	2.83	0.02	0.75	2.84	0.04	1.29
3.00	3.03	0.02	0.61	3.05	0.03	1.09
5.80	5.77	0.02	0.41	5.79	0.07	1.15
6.00	6.04	0.01	0.18	6.07	0.08	1.27
钠/（mmol/L）
115.00	114.60	0.37	0.32	116.10	1.31	1.13
120.00	118.80	0.36	0.30	120.20	0.96	0.80
155.00	154.70	0.40	0.26	156.20	1.27	0.81
160.00	161.30	0.73	0.45	162.10	2.09	1.29
总钙/（mmol/L）
1.50	1.48	0.01	0.90	1.49	0.02	1.15
1.70	1.73	0.01	0.54	1.71	0.02	1.46
3.30	3.33	0.02	0.72	3.36	0.04	1.30
3.50	3.42	0.01	0.37	3.45	0.04	1.09

项目	批内			批间
项目	x/（mmol/L）	s/（mmol/L）	CV/%	x/（mmol/L）	s/（mmol/L）	CV/%
钾/（mmol/L）
2.80	2.83	0.02	0.75	2.84	0.04	1.29
3.00	3.03	0.02	0.61	3.05	0.03	1.09
5.80	5.77	0.02	0.41	5.79	0.07	1.15
6.00	6.04	0.01	0.18	6.07	0.08	1.27
钠/（mmol/L）
115.00	114.60	0.37	0.32	116.10	1.31	1.13
120.00	118.80	0.36	0.30	120.20	0.96	0.80
155.00	154.70	0.40	0.26	156.20	1.27	0.81
160.00	161.30	0.73	0.45	162.10	2.09	1.29
总钙/（mmol/L）
1.50	1.48	0.01	0.90	1.49	0.02	1.15
1.70	1.73	0.01	0.54	1.71	0.02	1.46
3.30	3.33	0.02	0.72	3.36	0.04	1.30
3.50	3.42	0.01	0.37	3.45	0.04	1.09

项目	Y	X	偏差	1/3 TEa
钾	2.81	2.8	0.01	0.17
	3.01	3.0	0.01	0.17
	5.81	5.8	0.01	0.17
	6.01	6.0	0.01	0.17
钠	115.56	115.0	0.56	1.30
	120.54	120.0	0.54	1.30
	155.37	155.0	0.37	1.30
	160.35	160.0	0.35	1.30
总钙	1.52	1.5	0.02	0.08
	1.72	1.7	0.02	0.08
	3.36	3.3	0.06	0.08
	3.57	3.5	0.07	0.08

项目	Y	X	偏差	1/3 TEa
钾	2.81	2.8	0.01	0.17
	3.01	3.0	0.01	0.17
	5.81	5.8	0.01	0.17
	6.01	6.0	0.01	0.17
钠	115.56	115.0	0.56	1.30
	120.54	120.0	0.54	1.30
	155.37	155.0	0.37	1.30
	160.35	160.0	0.35	1.30
总钙	1.52	1.5	0.02	0.08
	1.72	1.7	0.02	0.08
	3.36	3.3	0.06	0.08
	3.57	3.5	0.07	0.08

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Consistency of abnormal results before and after re-determinations based on K⁺,Na⁺ and total calcium determinations

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