This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics **Revised: February 2021 (6th edition)
Marketing Notification No. 13A2X00197218100 *Revised: January 2017 (5th edition) This package insert must be read carefully prior to use.
Total protein assay kit for blood tests 2. Features
(Classification No.: 30181001) The measurement is hardly affected by turbidity of the solution. QUALIGENT TP Procedural Precautions * **
1. Properties of Samples and Sampling Methods
General Precautions ** 1) Samples 1. This product is for in vitro diagnostic use, and Serum and plasma (heparin plasma, EDTA must not be used for any other purposes. plasma, citrated plasma and NaF-EDTA 2. Clinicians should make a comprehensive clinical plasma) may be used. decision based on assay results in conjunction with 2) Storage of samples clinical symptoms and other examination results. If the isolated serum or plasma sample cannot 3. For the effects of an administered drug on the be tested on the same day, specimens should measured value, carefully read the Precautions for be stored as follows4): Use in the package insert of the drug, especially 2–10C: for tests within 1 mouth the section about the effects on laboratory test ≤ -20C: for tests after more than 1 month. results. Please also read carefully the “2. Bring samples to room temperature (15– Interfering Substances,” in the “Procedural Precautions” section, as well as “2. Precautions for 30C) before use. Assessment” in the “Assessment of Assay Results” 2. Interfering substances section, of this package insert. Assay results are not affected by free bilirubin (up 4. This product should be used only as directed in this to 20 mg/dL), conjugated bilirubin (up to 20 package insert. Reliability of results cannot be mg/dL), formazin turbidity (up to 3000 FTU), or guaranteed if there are any deviations from the ascorbic acid (up to 50 mg/dL). Hemolyzed instructions in this package insert. samples result in artifactual elevation of the 5. If the reagent accidentally comes in contact with protein level. eyes and/or mouth, rinse immediately with ample 3. Others water as first aid, and consult the doctor if 1) Always use Serum Multicalibrator (SEKISUI), required. Seronorm Multicalibrator, Seronorm Human or 6. Carefully read the operating instructions for each Anaserum ALB・TP Standard Solution for type of automated analyzers prior to using this calibration. product. Parameters for each type of analyzers are 2) Precautions for assay range available, and can be requested from SEKISUI If the concentration of sample exceeds assay MEDICAL CO., LTD. if required. range, dilute the sample with saline and repeat 7. Perform a quality control test prior to assay to the measurement. ensure accuracy. ** Dosage/Administration (Assay Procedure) * Description (Kit Components) * ** 1. Preparation of reagents Component : Ingredients Reagent: TP Coloring Solution is ready to use. TP Coloring Solution: 2. Assay Procedure Copper sulfate (II) pentahydrate This product is compatible with Hitachi 9000 series and LABOSPECT series automated Intended Use analyzers. Assay procedure is indicated below. Measurement of total protein in serum or plasma Sample Reagent 37C Measurement + ────▶ Total protein is the general term for all proteins with 2.1 L 180 L (Absorbance※) 10 min various functions. Changes of the total protein level reflect change of physiological function and damage ────▶ Calculation of concentration or disease affecting organs/tissues of the body. ※ Absorbance: The difference in absorbance between Assay Principle 700 nm and 546 nm 1. Assay Principle Calibration material: Serum Multicalibrator Protein in the samples reacts with the Biuret (SEKISUI), Seronorm Multicalibrator, Seronorm reagent to form a red-purple complex. The total Human or Anaserum ALB・TP Standard Solution protein level is determined by measuring the (Manufacture's assigned value) absorbance of this red-purple complex. Reagent blank: Purified water or saline Biuret reagent ** Protein Complex (red-purple color) Assessment of Assay Results * 1. Reference standard range2) 6.6–8.1 g/dL (Within the JCCLS common standard) 1 discarded as medical waste or industrial waste 2. Precautions for Assessment according to the waste disposal regulations. There may be reactions or interfering reactions 4) The reagents should be disposed of in with non-target substances. If assay results appear accordance with the Water Pollution Control act to be unreliable, repeat the measurement (if or related regulations. necessary, after dilution) or try another analytical 4. Other precautions methods. 1) Do not use the containers for other purposes. 2) Do not take apart the reagent cartridge before Performance * use. 1. Sensitivity 1) Reagent blank: absorbance being equal to or Storage and Shelf Life * lower than 0.05 1. Storage temperature: room temperature (1–30C) 2) Sensitivity: The absorbance is 0.21–0.25 per 6 2. Shelf life: 2 years from the date of manufacture g/dL of albumin. (The expiration date is printed on the outer 2. Accuracy: 90–110% of the expected assay value package.) 3. Within-run Reproducibility: Coefficient of variation ≤ 3% Packaging * (Test methods used for 1. –3. are in-house methods.) Name Package 4. Measurement Range5): (On a Hitachi 9000 series Set TP automated analyzer) (Cassette for Coloring 0.3–12 g/dL ×2 Hitachi 9000 Solution 5. Correlation5) QUALIGENT series) 1 × 27.0 mL 1) Serum N=70 r=0.979 y=0.94x+0.43 TP Control method: Approved in vitro diagnostic L set TP Coloring (Biuret test) (Set for Hitachi Solution ×2 LABOSPECT 2) Plasma N=150 r=0.999 y=1.02x –0.11 1 × 46 mL series) Control method: Approved in vitro diagnostic (Biuret test) ** 6. Standard Material References * SRM927 (NIST) 1) Gornall, A.G., et al.: J. Chem, 177, 751, 1949. 2) Kanai M. (supervising editor): Kanai’s manual of Precautions for Use or Handling * clinical laboratory medicine. 35th ed. Tokyo: Kanehara Shuppan; 2020. Japanese. 1. Precautions for Handling (to Ensure Safety) 3) Akiyoshi M., Shimizu F. (supervising editors): 1) All samples used in the test should be handled Clinical laboratory methods and diagnosis course as a material possibly infected with HIV, HBV, 14, Tokyo: Ishiyaku Shuppan; 1972. Japanese. HCV, or other viruses. To prevent infection, use 4) Sasaki M. et al.: Sampling of constituents of the disposable gloves and avoid mouth pipetting human body, Tokyo: Kodansha; 1972. Japanese. during the test. 5) SEKISUI MEDICAL CO., LTD. In house data. 2) The TP Coloring Solution is an alkaline Japanese. solution. If it is accidentally ingested or comes into contact with the eyes or skin, immediately Contact rinse the area with water and seek medical SEKISUI MEDICAL CO., LTD. treatment, if necessary. [email protected] 2. Precautions for Use 1) This product should be stored as directed, without freezing. Freezing can deteriorate the reagents, which can produce inaccurate results. Therefore, avoid using the reagents which have been previously frozen. 2) Do not use expired reagents. Use of such reagents cannot guarantee the reliability of measurement values. 3) Do not perform the assay under direct sunlight 3. Precautions for Disposal 1) Before disposal, used samples and their containers must be immersed in sodium Manufacturer * hypochlorite solution at a concentration of SEKISUI MEDICAL CO., LTD. greater than 0.1% for longer than 1 hour or 1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan autoclaved at 121ºC for 20 minutes. 2)To prevent infections from spilled samples or "QUALIGENT" and "Anaserum" are trademarks or registered trademarks of SEKISUI MEDICAL CO., solutions containing samples, wipe the spilled LTD. in Japan and/or other countries. area thoroughly with disinfectants such as All other brands, product names and service names sodium hypochlorite solution at a concentration are trademarks or registered trademarks of their of greater than 0.1%. respective companies. 3) The reagents and treated samples should be 2