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Objective To evaluate the performance of emergency test and the applicability under complex field conditions of biochemical modules of field point-of-care test ( POCT ) system ( type A ) .Methods The precision and anti-interference ability of albumin ( ALB ) , total bilirubin ( TBIL ) , alanine transaminase ( ALT ) , aspartate transaminase (AST),blood area nitrogen(BUN),creatinine(CREA),uric acid(UA),lactate dohydrogenase(LDH),creatine kinase ( CK) ,and glucose( GLU) detected by field POCT system( A) were analyzed according to standards formulated by National Committee for Clinical Laboratory Standards(NCCLS).Field POCT system(A) and Coulter Beckman AU2700 automatic biochemical analyzer were used to detect the serum of 22 clinical cases respectively.After simulating the field environment by adjusting the temperature and humidity, we compared the results of mixed serum under different environment conditions. Results The coefficients of variation in total precision of ALB,TBIL,ALT,AST,BUN,CREA,UA,LDH,CK,and GLU detected by field POCT system(A) were 3.34%,6.54%,6.01%,4.80%,3.95%,5.59%,3.33%,6.19%,7.40%,and 4.56%(LevelⅠ);and 3.08%,4.47%,4.02%,4.31%,3.76%,4.22%,2.93%,5.25%,6.39%,and 4.35%(LevelⅡ) respectively.When triglycerides( TG) level was at 21 mmol/L, the interference rate was below 10%.When bilirubin level was at 120 μmol/L, the interference rate of ALT,AST and CREA was -33.33%,-22.99%,20.00%(LevelⅠ), and -22.13%,-14.55%,and 8.70%(LevelⅡ),respectively.When its level was at 240 μmol/L, the interference rate of UA was -16.67%and -24.69%, respectively at two levels;if hemoglobin( Hb) was at 170 mg/dl, the interference rate of TBIL and LDH was 20.00%,and 99.26%(LevelⅠ),and 15.38%,and 40.79%(LevelⅡ),respectively;if it was at 340 mg/dl, the interference rate of ALT and AST was 9.84% and 13.79%(LevelⅠ), and 12.30%,and 12.27%(LevelⅡ),respectively;if it was at 510 mg/dl, the interference rate of CREA,UA and Ck in LevelⅠwas 26.67%, 16.67%,and 11.74%.The R2 of linear regression between field POCT system( A) and AU2700 automatic biochemical analyzer were 0.961,0.995,0.989,0.995,0.990,0.989,0.989,0.963,0.978,and 0.993, respectively.The POCT system could not work at 35℃ or higher temperature, and there was no difference in the results of detection between temperatures of 10-30℃or RH of 70%-90% and normal temperature and humidity(20℃,RH 50%) (P>0.05). However, the result of ALT and CK at high temperature and humidity was significantly higher than at normal temperature and humidity(P<0.001,and P=0.011, respectively).Conclusion The biochemical module of field POCT system(A) has a good correlation with the common large biochemical analyzer, and its precision meets the requirement of laboratory detection, but jaundice and hemolytsis can interfere in several tests to varying degrees.The POCT system can basically ensure accurate detection under field conditions of temperature and humidity, but should not work under extreme environments.
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Objective To evaluate the analytical performance of Mindray BS‐820 automatic biochemical analysis system used in primary hospitals in Guangzhou area for verifying whether its performance meeting the clinical requirements .Methods Accord‐ing to the EP5‐A2 ,EP6‐A ,EP7‐A2 and EP‐17A files recommended by CLSI and the Pharmaceutical Industry Standard of the Peo‐ple′s Republic of China YY/T0654‐2008 ,the precision ,linear rang ,anti‐interference capability ,sensitivity and carry‐over rate of the Mindray BS‐820 automatic biochemical analysis system were evaluated by adopting 16 routine biochemical items .Results The pre‐cision results of all 16 analyzing items conducted by the Mindray BS‐820 automatic chemical analysis system conformed to the re‐quirements .The results of 15 items showed good linear relation during the testing range (r≥0 .997 9) .In 16 biochemical items ,the anti‐interference capability of TBIL ,TP ,TC ,TG ,LDL ,HDL ,UREA and Ca to bilirubin ,triglyceride and hemoglobin conformed to or were higher than the anti‐interference capability declared by manufacturer ,but among other 8 items ,the anti‐interference capabil‐ity of 3 items was lower than that declared by manufacturer .The limit of blank(LOB) of all 16 analyzing items was less than LOB in the kit instruction .The carry‐over rate of Glu was 0 .02% ,less than 0 .50% .Conclusion This instrument has good precision , sensitivity and low carry‐over rate(0 .02% ) ,the linear range is ideal ,r≥0 .997 9 ,the anti‐interference capability basically satisfies the clinical needs .Therefore this instrument is suitable for the use in the middle‐small scale laboratory department .
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Objective To evaluate and select the dilution for high blood and urinary amylase among wet chemical & dry chemical de‐tection system ,hope to screen the optimum dilution for different measurement system and specimen type .Methods Pure water (H2 O) ,nor‐mal saline (NS) ,7% bovine serum albumin(7% BSA) ,low amylase specimen of serum and urine selected as candidate dilution .The high amylase specimen was diluted ,then was measured among wet chemical analyzer and dry chemical analyzer ,then the bias and correlation was evaluated according to the professional standard of National health and family planning commission of china .Results For high amylase ser‐um specimen ,the same dilution resulted in different bias between two detecting system .The bias of H2 O ,7% BSA and low amylase serum were less than the TEa (total error allowance) regulated by professional standard in wet chemical analyzer .Of them ,the low amylase serum was the best .In dry chemical analyzer ,the bias of H2 O ,NS and low amylase serum were no less than the professional standard .Of them ,NS was the best .For high amylase urine specimen ,the bias of H2 O and low amylase urine were less than the professional standard in wet chem‐ical analyzer ,and the low amylase urine was the best .In dry chemical analyzer ,only the bias of low amylase urine met the requirement of professional standard .The evaluation of linearity indicated that NS was unfit to the dilution for high amylase serum in wet chemical analyzer and for high amylase urine in dry chemical analyzer ,7% BSA was unsuitable to be the dilution for high amylase serum .Conclusion The effect of same dilution on different detecting system is different .The most suitable dilution is low amylase serum and urine for high amylase serum and urine specimen respectively in wet chemical analyzer ,and the suitable dilution is NS and low amylase urine respectively in dry chemical analyzer .
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Objective To analyze the comparability of potassium results detected by blood-gas analyzer and dry chemical analy-zer .Methods Dry chemical detection system was used as comparison method (X) ,and blood gas analyzer systems was used as the experimental method (Y ) .Arterial blood samples collected from ICU newborns were detected respectively by the two methods .If SE of medical decision level was less than or equal to 1/2 TEa decided by CLIA′88 ,the results was acceptable .Results There was a linear correlation in potassium concentrations of the two detection systems(r=0 .976 ,P<0 .01) .But among three medical decision levels ,the SE of the two detection systems only acceptable at 3 .0 mmol/L .Conclusion The potassium concentration of blood gas analyzer is lower than that of dry chemistry analyzer .The potassium concentration of dry chemistry analyzer should be taken as a reference to diagnose and clinical treatment .
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Objective To perform the comparative analysis on the use situation of 3 kinds of dry chemical analyzers according to the industrial standards YY/T0655-2008.Methods With the Roche Cobas P800 automatic biochemical analyzers as the reference instrument,the accuracy,intra-assay precision,linearity,etc.in 3 kinds of dry chemical analyzers were evaluated.Results 3 kinds of dry chemical analyzers met the requirements of the industrial standards YY/T0655-2008,but the precision of imported instrument was significantly better than that of the domestic instrument.Conclusion In order to ensure the comparability and consistency of the detection results among instruments,the instruments should be regularly calibrated and performed the comparative experi-ments,the premise of calibration and comparison should be using 1/4 of the precision level in the CLIA′88 indicators as the indica-tor,not satisfying with the precision requirements in YY/T0655-2008,only in this way can the waste of blood and donors going a-way be avoided.
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Objective To perform the performance evaluation on the automatic biochemical analyzer with the national standards (YY/T0654-2008).Methods The stray light,absorbance accuracy,absorbance stability and repeatability,absorbance linearity, sample carrying contamination rate,sampling accuracy and repeatability,repeatability of TP,ALT,BUN,etc.in the ADVIA 2400 automatic chemical analyzer were detected according to the national standard(YY/T0654-2008).Results The stray light detection value of the ADVIA 2400 analyzer was 6.2Abs;the error of absorbance accuracy was 0.002 9 and 0.007 5 on the absorbance of 0.5Abs and 1.0Abs;the absorbance stability was 0.000 52;the coefficient variation(CV)of absorbance repeatability was 0.12%;the absorbance linearity range was 0.000 2-3.305 7;the sample carrying contamination rate was 0.1% The sampling accuracy and repeatability conformed to the requirement;CV of repeatability of TP,ALT and BUN was 0.6%,1.2% and 1.2% respectively. Conclusion The measurements of various items of the ADVIA 2400 automatic biochemical analyzer meet the national standard (YY/T0654-2008).
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When analyzing samples containing paraproteins, various interference effects are encountered in the clinical laboratory. Precipitation of paraproteins mostly interferes with the assays that use photometric detection. Herein, we present a case of a patient with multiple myeloma who had paraproteins and spuriously elevated total bilirubin levels (31.1 mg/dL), which were measured by using Roche total bilirubin assay on the Modular DPE (Roche Diagnostics, Switzerland) chemical analyzer. The total bilirubin concentration reduced from 31.1 mg/dL to 1.5 mg/dL, when tested after three fold dilution of the sample on Modular DPE chemical analyzer.