Comparison of Improvacuter EDTA Tube with BD Vacutainer EDTA Tube for Routine Hematological Analysis: Clinical Significance of Differences, Stability Study, and Effects of K₂ and K₃ EDTA

BACKGROUND: The type of blood collection tubes is an important pre-analytical factor that may affect test results. We compared the test results of the Improvacuter EDTA tube (Improve Medical, China) with those of the currently used BD Vacutainer EDTA tube (Becton Dickinson, USA) and investigated the effects of K₂ and K₃ EDTA additives. METHODS: Peripheral blood samples from 100 outpatients were collected into the aforementioned tubes. The samples were evaluated for 17 hematological analytes, hemoglobin A1c, and erythrocyte sedimentation rate (ESR). The results were analysed using the paired t-test for comparison. Bland-Altman plots and Passing-Bablok regressions were used for analytes with statistically significant differences in the comparison. If the differences were not within total allowable error, they were defined as clinically significant. For stability testing, the initial results were compared against those from samples preserved for 72 hours. White blood cell count, red blood cell count, platelet count, and mean corpuscular volume from both tubes were compared to ascertain the differences between K₂ and K₃ EDTA additives. RESULTS: Hematocrit, mean corpuscular volume, mean corpuscular haemoglobin concentration, and ESR showed statistically significant differences (P<0.05) between two tubes. However, these differences were not considered clinically significant. Most of the analytes presented statistically significant differences in stability test; however, they were not clinically significant either. Additionally, the differences in the hematological parameters shown in the outcome were not clinically significant, depending on the type of the EDTA additives. CONCLUSIONS: The results indicate that Improvacuter EDTA tubes showed satisfactory performance. We conclude that the tubes are suitable for common clinical hematological use.

A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes

BACKGROUND: Because blood collection tube can affect the results of various laboratory tests, it is necessary before using a newly developed product to verify its performance stringently and objectively. We compared the performance of Ampulab EDTA and sodium citrate tubes (Soyagreentec, Korea) with that of Vacutainer tubes (BD, USA) in accordance with international guidelines. METHODS: This study was performed as a multicenter study of Chung-Ang University Hospital and Seoul National University Hospital to evaluate the performance of two different instrument platforms. We performed the precision test according to CLSI GP34-A, the accuracy test according to CLSI EP09-A2-IR, and the vacuum test according to CLSI H1-A5 as well as stability, and aseptic condition tests. We evaluated 3 lots of Ampulab tubes for their precision, accuracy, vacuum, and aseptic condition. RESULTS: In precision test, the total precision levels of Ampulab tubes in most measurands were desirable or allowable. The results of mean corpuscular hemoglobin concentration, platelet distribution width, basophil, and reticulocyte counts for Ampulab tubes showed imprecision beyond allowable limits, but were similar to those of Vacutainer tubes. In the accuracy test, the bias in most measurands, except for the mean platelet volume, was within allowable limits. In the stability test, Ampulab showed similar performance to Vacutainer. In tests of the vacuum and aseptic conditions, Ampulab fulfilled both requirements. CONCLUSIONS: The performance of Ampulab EDTA and sodium citrate tubes was equivalent to that of Vacutainer tubes.

A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes

BACKGROUND: Because blood collection tube can affect the results of various laboratory tests, it is necessary before using a newly developed product to verify its performance stringently and objectively. We compared the performance of Ampulab EDTA and sodium citrate tubes (Soyagreentec, Korea) with that of Vacutainer tubes (BD, USA) in accordance with international guidelines. METHODS: This study was performed as a multicenter study of Chung-Ang University Hospital and Seoul National University Hospital to evaluate the performance of two different instrument platforms. We performed the precision test according to CLSI GP34-A, the accuracy test according to CLSI EP09-A2-IR, and the vacuum test according to CLSI H1-A5 as well as stability, and aseptic condition tests. We evaluated 3 lots of Ampulab tubes for their precision, accuracy, vacuum, and aseptic condition. RESULTS: In precision test, the total precision levels of Ampulab tubes in most measurands were desirable or allowable. The results of mean corpuscular hemoglobin concentration, platelet distribution width, basophil, and reticulocyte counts for Ampulab tubes showed imprecision beyond allowable limits, but were similar to those of Vacutainer tubes. In the accuracy test, the bias in most measurands, except for the mean platelet volume, was within allowable limits. In the stability test, Ampulab showed similar performance to Vacutainer. In tests of the vacuum and aseptic conditions, Ampulab fulfilled both requirements. CONCLUSIONS: The performance of Ampulab EDTA and sodium citrate tubes was equivalent to that of Vacutainer tubes.

Effect of different placed time for vacutainer and specimen on electrolyte test results / 上海预防医学

Objective] To study the effect of different placed time for vacutainer and specimen on the results of emergency electrolyte detection . [ Methods] With heparin lithium anticoagulation tube and common coagulation vacuum tube , electrolytes were detected at 30 minutes,one hour and two hours af-ter extracting blood . [ Results] At 30 minutes and one hour after extracting blood ,the levels of K +and Na+of the plasma group were significantly lower than those of the serum group (P<0.05).With the ex-tension of specimen placed time , the levels of K +and Na +of the plasma group were becoming higher than those previously ,and at two hours the difference had statistical significance ( P<0 .05 ) .There was not ob-vious difference found in the levels of K +, Na +and Cl -of the serum group at different placed times ( P>0.05).But the levels of CO2 of both the plasma group and the serum group were significantly lower than those previously with the extension of specimen placed time , and the difference had statistical significance (P<0.05). [Conclusion] It is indicated that the using of different vacutainers effects electrolyte de-tection.With the extension of specimen placed time , the levels of K +and Na +of the plasma group increase gradually , and the levels of CO 2 of the plasma group and the serum group both decrease gradually .

Evaluation of the Vacutainer Gel Plasma Tube for Common Clinical Chemistry Assays / 임상검사와정도관리

BACKGROUND: Plasma specimens are recently used instead of serum in clinical chemistry to improve (test result turnaround time, TAT). We evaluated the performance of lithium heparin gel plasma separating tube in comparison to existing vacutainer gel serum tube in common clinical chemistry assays. METHODS: Total 52 subjects who had visited the health promotion center were included in the study. Lithium heparin plasma tubes and serum tubes were tested for 30 clinical chemistry items and 3 cardiac markers. Test results were analyzed by calculation of mean bias and percent difference. RESULTS: The performance of the lithium heparin plasma tube was considered to be clinically equivalent to the serum tube for all assays except for potassium. The difference of potassium levels between lithium heparin plasma tube and the serum tube was -7.32%. Test results of some analytes including glucose, lactate dehydrogenase, total CO2 and potassium using the lithium heparin tube were significantly changed after 24 hours of storage. CONCLUSIONS: The lithium heparin plasma tube provided acceptable results comparison to the existing serum separating tube in common clinical chemistries and can be used for reducing, TAT. However, the stability of plasma gel tubes on 24 hours of storage was unstable in some analytes, it requires attention.

Comparison of Three Plastic Tubes (Two Gongdong Vacuum Blood Tubes and Improve Vacuum Blood Collection Tube) with BD Vacutainer Tube for 37 Laboratory Tests / 임상검사와정도관리

BACKGROUND: Recently, three collection tubes manufactured in China (Zhejiang Gongdong Medical Plastic Factory, Guangzhou Improve IVD) were introduced. We compared the performance of the three tubes with the existing BD Vacutainer tube (BD, USA) for common analytes. METHODS: Twenty healthy volunteers were recruited for this study. Routine chemistry, thyroid function test, and hematologic test were analyzed with these tubes, and compared the results by Student paired t-test and Bland-Altman Plot. For stability test, the initial results for each tube were compared with results of 72-hour preserved samples. RESULTS: For Gongdong tube, total bilirubin (T-BIL), glucose (GLU), phosphorus (PHOS), hemoglobin (Hb) and mean corpuscular volume (MCV) were lower, and total protein (TP), AST, direct bilirubin (D-BIL), unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC) and free thyroxine (FT4) were higher than those of BD tube. For Gongdong2 tube, ALT, T-BIL, PHOS, lactate dehydrogenase and MCV were lower, and D-BIL was higher than that of BD tube. For Improve tube, corpuscular hemoglobin concentration mean (CHCM) was lower, and albumin (Alb), blood urea nitrogen (BUN), creatinine (Cr) and FT4 were higher than those of BD tube. For three tubes, triiodothyronine (T3) was lower, and triglyceride (TG) and magnesium (Mg) were higher than those of BD tube (P<0.05). All statiscally different cases were clinically acceptable by CLIA'88 programs except D-BIL, UIBC, TIBC, Hb, MCV and CHCM those were not considered to be clinically significant. Most of stability tests showed variation within ten percents. CONCLUSIONS: The three tubes showed satisfactory results compared with existing BD Vacutainer tube. We concluded that the tubes are suitable for common laboratory tests.

Evaluation of Green Vac-Tube in Clinical Laboratory Tests / 임상검사와정도관리

BACKGROUND: Vacuum tubes are widely used in the clinical laboratory for routine tests. We compared a newly developed Green Vac-Tube (SPM, Gimje, Korea) with Vacutainer (BD, Franklin Lakes, NJ, USA) and Vacuette (Greiner Bio-One, Frickenhausen, Germany) in routine chemistry and hematology tests. METHODS: A total of 101 volunteers, 81 patients and 20 healthy volunteer, were recruited and we had collected blood samples with three kinds of EDTA tubes and those of serum separating tubes. The samples were evaluated for chemistry and hematology tests using TOSHIBA 200FR (Toshiba, Tokyo, Japan) and ADVIA (Siemens, Deerfield, IL, USA) respectively. Their results were statistically analyzed by paired t-test and Bland-Altman plot. RESULTS: Their clinical utilities were examined by CLIA'88 programs. Paired t-test analysis revealed that the results of ALP, AST, total bilirubin, CO2, Hct and MCV showed statistically significant differences between Green Vac-Tube and previously used two vacuum tubes. Similar significant differences were also observed between previous two vacuum tubes. And 194 (4.37%) cases among 5,151 cases were in the critical region by Bland-Altman plot. All different cases, except Na+, K+ however, were clinically acceptable by CLIA'88 programs. CONCLUSIONS: Green Vac-tube has good analytical performance compared to previously-used tubes.

Comparison of Two New Plastic Tubes (Sekisui INSEPACK and Green Cross Green Vac-Tube) with BD Vacutainer Tubes for 49 Analytes / 대한진단검사의학회지

BACKGROUND: Becton Dickinson (BD) Vacutainer tubes are the most widely used vacuum system for collection of blood in clinical laboratories. We compared the performance of two new tubes, Sekisui INSEPACK tube and Green Cross Green Vac-Tube, with the existing BD Vacutainer tubes for 49 common analytes. METHODS: A total of 20 apparently healthy volunteers were recruited for this study. For rountine chemistry and thyroid function tests, we compared the results of two new vacutainer tubes and BD Vacutainer tubes with those of BD glass tubes at t =0 hr by student paired t test. Hematology and coagulation test results of the two new vacutainer tubes were compared with those of BD Vacutainer tubes at t =0 hr. To study the stability of each analyte, results at t =24 +/- 2 hr, t =72 +/- 2 hr, and t =168 +/- 2 hr were compared with those at t =0 hr for each tube. RESULTS: Although paired t test analysis revealed statistically significant differences between two tested tubes and existing BD Vacutainer tube in several tests (total protein, total bilirubin, alkaline phosphatase, glucose, uric acid, calcium, inorganic phosphorus, direct bilirubin, triglyceride, HDL-cholesterol, LDL-cholesterol, lactate dehydrogenase, triiodothyronine, and thyroxine), these differences were not considered clinically significant. Stability of two new vacuum tubes for each analyte was similar to that of the BD Vacutainer tube. CONCLUSIONS: Sekisui INSEPACK tube and Green Cross Green-Vac Tube showed a satisfactory analytical performance compared with existing BD Vacutainer tubes. We conclude that these two new plastic vacutainer tubes are acceptable for the commonly ordered laboratory tests.

Comparison of Sekisui Trank Insepack and BD Vacutainer Plastic Citrate Tubes for Routine Coagulation Assays / 임상검사와정도관리

BACKGROUND Coagulation assays can be easily affected by preanalytical variables, including the factors associated with the blood collection tube. Recently the Sekisui Trank Insepack (Sekisui Chemical Co., Ltd, Osaka, Japan; Insepack) blood collection tubes were introduced into Korea. The aim of this study was to compare the results of routine coagulation assays using the Insepack with those using BD Vacutainer (BD, Franklin Lakes, NJ, USA; Vacutainer) tubes, which are most widely used in Korea. METHODS: Paired blood samples from 64 patients were drawn into Insepack and Vacutainer 3.2% citrate tubes. The results of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, and fibrin/fibrinogen degradation product (FDP) were determined in parallel. RESULTS: No statistically significant differences were observed between Insepack and Vacutainer tubes for PT, fibrinogen, and FDP tests. For APTT which showed the significant differences between the results in the two tubes the mean difference was small (0.8 seconds), and it was not considered clinically significant. CONCLUSIONS: The results of this study suggest that Insepack tubes can be used in place of Vacutainer tubes for routine coagulation assays.