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Point-of-care testing (POCT) has developed rapidly in various fields including medical health, customs quarantine, agriculture, graziery, forestry, fire-fighting, environment and food testing. It poses a huge challenge to the traditional inspection mode. Yet POCT still has many problems in terms of technical ability, quality control, regulation and industry-university-research cooperation and so on. Thus it is necessary for the health administrative departments, manufacturers and hospitals to establish consensus, and implement the total quality management system. The establishment of an independent evaluation system and the application of advanced quality control technologies of POCT is also essential given its particularity. This article focuses on the POCT application status and quality management in Shanghai based on the series of quality management measures for the POCT project carried out by the Shanghai Center for Clinical Laboratory, and raises some thoughts and suggestions for the existing problems.
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Objective To assess the interference by calcium dobesilatein 7 peroxidase-baseduric acid assays and to determine its clinical significance.Methods In the in vitro experiments, uric acid in pooled serum with final concentrations of calcium dobesilate additions (0, 2, 4, 8, 16, 32, and 64μg/ml) were measured by 7 peroxidase-based assays.Percent Bias (%) was calculated relative to the drug-free specimen.In the in vivo experiments, changes in serum uric acid and calcium dobesilate concentrations were observed before and after calcium dobesilate administration ( baseline, 0 h, 1 h, 2 h, 3 h, 4 h, 6 h ) involunteers.The interference in different assays was assessed compared with LC-IDMS/MS method. Calcium dobesilate levels in 40 specimens from those taking calcium dobesilate were measured by HPLC method.Of the 40 specimens, 10 were selected to analyse the levels of uric acid by both peroxidase and UV measurement method to assess the impact in clinical status.Results In the in vitro study, concentrations of uric acid measured by 7 peroxidase-based assays were reduced by -6.3%to -21.2%compared with drug-free serum, when theconcentration of calcium dobesilate was16μg/ml.In the in vivo study, comparedto UA levels at 0 h, the biasesof serum uric acid determined by peroxidase method after calcium dobesilate administration(1 h, 2 h, 3 h, 4 h, 6 h) were of -3.33%, -6.79%, -7.49%, -6.07%, -4.09%, respectively.The observed uric acid concentrations for 8 participants measured by enzymatic assays were inhibited by -3.75% to -6.89% at 0 hour and by -16.9% to-22.22% at 2 hours relative to the concentrations measured by the LC-IDMS/MS method. Conclusions Calcium dobesilate produced a clinically significant negative interference with uric acid in all peroxidase-based uric acid assays,which may result in false evaluation of uric acid level in clinical status.Significant differences in the degree of interference were observed among the assays.
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Objective To compare the concordance of five automated 25OHD immunoassays with liquid chromatography tandem mass spectrometry method ( LC-MS/MS) .Methods During May to July in 2014, 245 clinical serum samples that requested 25OHD tests were selected, with a total 25OHD range of 2.8 ng/ml-64.0 ng/ml, in which 154 samples did not contain 25OHD2 and 91 samples contains both 25OHD2 and 25OHD3 .To used a LC-MS/MS method that built in our laboratory to measure 25OHD, five commercial automated chemiluminescent immunoassays from Abbott Diagnostics ( A ) , DiaSorin LIASON (B), IDS-iSYS(C), Roche Diagnostics(D), and Siemens ADVIA Centaur(E).Taking the reference method LC-MS/MS as a standard , to compared the concordance and performance of the five automated 25OHD immunoassays.And used the commonly accepted cutoffs for 25OHDdeficiency (<20 ng/ml), and insufficiency ( 20 -30 ng/ml ) , and sufficiency (≥30 ng/ml ) to compare the uniformity of different methods .Statistical analysiswere performed by MedCalc software , Passing & Bablok regression , Bland &Altaman plots and Box and whisker plots were performed to compare the differences of the methods .Results The medium ( range:2.5% -97.5%) 25OHD of the 245 serum samples of the six methods was 23.5 (5.8-44.2) ng/ml(LC-MS/MS),20.6 (7.1-43.5)ng/ml(A),19.0 (5.4-38.0) ng/mL (B),23.0 (10.0-38.1) ng/ml(C),20.1 (5.1 -46.0) ng/ml (D),31.3 (12.3 -71.1) ng/ml (E), respectively .Passing and Bablok regression showed that method B had the best correlation coefficient with LC-MS/MS (r=0.894), while methods A, C and D had relatively small bias compared withLC-MS/MS and method E had the large bias .If the serum samples did not contain 25OHD2 , all the five automated immunoassays correlated well with LC-MS/MS with a correlation coefficient higher than 0.84, and B has the best correlation with LC-MS/MS ( r=0.930 ) .While all the correlation coefficient between immunoassays and LC-MS/MS decreasedwhen analyzing the samplescontaining 25OHD2.Using the clinical cutoffs, A, B, C, D and E had a concordance of 68.6%, 64.9%, 67.8%, 70.6% and 51.8% compared with LC-MS/MS, respectively .Conclusions There are significant differences between different detection systems of 25OHD.All the immunoassays results were affected by the existence of 25OHD2 .The concordance of serum 25OHD resultswas poor between different methods , and it may be necessary to built exclusive cutoffs for different methods.
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ObjectiveTo observe the effect of the nine points for hemiplegia plus MOTOmed exercise training system on the lower-extremity function of the patients with post-stroke hemiplegia.MethodForty-five patients with post-stroke hemiplegia were randomized into 3 groups, 15 each.Group A was intervened by regular acupuncture treatment, group B was by the MOTOmed training system, and group C was by the nine points for hemiplegia during the exercise training by the MOTOmed system in addition to the regular acupuncture treatment. The National Institute of Health Stroke Scale (NIHSS) and Fugl-Meyer (FMA) scale were adopted for evaluation and comparison before intervention and after 4-week intervention.ResultBefore intervention, there were no significant differences in comparing the function of lower extremity among the three groups (P>0.05);after 4-week intervention, the observation indexes were improved in the three groups, and the improvement in group C was the most significant (P<0.05), and it was significantly different from that of group A and B at the corresponding time point (P<0.05). ConclusionThe nine points for hemiplegia plus MOTOmed exercise training can effectively improve the lower-extremity function in the patients with post-stroke hemiplegia.
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Through the research and analysis of patients' group ages, cultural level and profession structure. etc, combined with the requirement of new medical mode, the paper raises the cultural ethical accomplishment nurses should have, and gives examples to discuss the relationship between this accomplishment and nursing quality.