• Korean Journal of Clinical Laboratory Science
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• v.56 no.1
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• pp.32-42
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• 2024

This study compared the results of hemolyzed samples and re-collected samples to investigate a hemolysis influence and an acceptable hemolysis index (HI). Before and after hemolysis, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase (Amy), direct bilirubin (D-bil), total bilirubin (T-bil), creatine phosphokinase (CK), gamma glutamyl transferase (GGT), iron, potassium (K), lactate dehydrogenase (LDH), magnesium (Mg), phosphorus (Phos), total protein (TP), and uric acid (UA) showed significant results in the paired t-test. LDH, K, iron, AST, CK, GGT, TP, Amy and Phos had a high correlation between the degree of hemolysis and the results of samples. When comparing Roche's cut-off HI with HI^QChigh obtained using quality control (QC) high standard deviation (SD), AST, D-bil, CK, and LDH were similar, but Amy, GGT, K, iron, Phos, and TP were lower than the cut-off HI of Roche, while ALP and ALT were higher. Some analytes which showed no significant results in the paired t-test, were found to have significant results in HI>200. Hence, it is suggested that the hemolyzed sample should be rejected if HI>200. Based on this study that some analytes were affected when HI<100, we recommend to set the standard of hemolysis starting from HI>50.

• Journal of Chest Surgery
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• v.17 no.1
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• pp.157-166
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• 1984

These biologic test procedures are designed to test the suitability of P.V.C. made in Korea intended for parenteral preparation, which were based on the U.S. Pharmacopeia XIX "Biologic Test-Plastic Container", Official from July 1, 1975. Healthy adult human blood and rabbits weighing 2\ulcorner.2Kg were used for test materials. Sample P.V.C. were sampled from the medical equipments made in Korea randomly and Control P.V.C. were sampled from the standardized Cobe and Polystan P.V.C. tubes. P.V.C. extract was prepared from a homogeneous P.V.C. samples by incubating 60 square centimeters of the sample per 20 millimeters of sterile pyrogen-free saline at 70\ulcorner for 72 hours or autoclaving at 120\ulcorner for 1 hour. The Implantation Test was designed to evaluate the reaction of living tissue to the plastic by the method of the implantation of the Sample itself into animal tissue. The Systemic Injection Test, the Intracutaneous Test, and the remainders were designed to determine the biological response of animals to plastics by the single-dose injection of specific extracts prepared from a Sample. The results are as follows; 1.Implantation Test - No significant difference for reactions was noted between the Sample treated animal and the Control after 72 hours of implantation. 2.Systemic Toxicity Injection Test - No sign of toxicity and/or death immediately after injection and at 4, 24, 48 hours respectfully after injection. 3.Intracutaneous Test - None of the animals treated with the Sample showed a significantly greater reaction than the observed in the animals treated with Blank. 4.Pyrogen Assay-Only one animal treated with the Sample showed the maximal rise of rectal temperature about 0.2\ulcorner after 3 hours of injection, but remainders showed no change. 5.Hemolytic Index - The positive Control tube of distilled water exhibited complete hemolysis while the negative Control tube and P.V.C. extract were negative demonstrating no hemolysis. 6.Cell Morphology of Erythrocytes and Leukocytes on Stored, Heparinized Human Blood -- There was no significant difference in the morphology of either the Control or Sample extract. 7.Clotting Mechanism of Human Blood in vitro - After allowing to the P.V.C. extract at room temperature for 5 Hours and at 10\ulcorner for 24 hours, there was no appreciable difference in Prothrombin Time under these conditions. 8.Clotting Mechanism of Rabbit in vivo - At the termination of 5 days after intraperitoneal injection of the P.V.C. extract, no significant changes in Clotting Time were observed. According to the above results, it could be concluded that the P.V.C. made in Korea was acceptable for parenteral preparation, especially treated with physiologic saline and/or human blood.man blood.