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DH (No. 136784)

Reagent for External Diagnosis

Special Reagent for Fully Automatic Human Fecal Hemoglobin Analyzer

EXTEL^® HEMO AUTO

(Latex Agglutination Reaction Method)

Approval No. 21300AMZ00423000

This product is an external diagnostic preparation for medical use. It is not a test agent for general use. Before attempting to use this product, be sure to read through the attached leaflet.

[Summary]

In view of its convenience, fecal occult blood testing is used for examination to determine hemorrhage from the lower digestive tract, and especially for screening of colorectal cancer ¹⁾. Immunological fecal occult blood testing with the use of anti-human hemoglobin Ao antibody, in particular, has a superior sensitivity and specificity to the chemical techniques that have been used in the past. It also requires no restrictions on food intake. For these reasons, this method is extensively used ^{2), 3)}. Because a certain amount of time will inevitably elapse from the taking to the analyzing of the fecal specimen, the human hemoglobin will lose some of its activity in the meantime, leading to false negative results. The possibility of false negative results has been recognized as a problem inherent in this method and an improvement in human hemoglobin stability after sampling has been looked for ^{2), 3)}.

The EXTEL^® HEMO AUTO is a reagent for immunological occult blood testing in the stool that makes use of the latex agglutination reaction. It is characterized by a superior human hemoglobin stability after fecal sampling.

This reagent is used to determine human hemoglobin by a high-sensitivity, high-speed optical method based on the changes in turbidity due to the latex agglutination reaction.

<Characteristics>

This method is capable of determining human hemoglobin at high sensitivity and high speed.

This method provides a superior stability of the human hemoglobin after defecation.

This method has a wide measurement range (7 - 800ng/mL).

This method has a superior specificity and requires no restrictions on food intake before testing.

[Components]

The antibody sensitized latex suspension is provided with a master curve card.

All of the above reagents are sold separately.

Use as the standard the Hemoglobin Standard for Fecal Occult Blood Measurement that is sold separately.

For accuracy management, use HM Control that is sold separately.

[Intended Use]

For measurement of the concentration of fecal hemoglobin.

[Test Principle]

Human fecal hemoglobin is caused to undergo an antigen-antibody reaction with antihuman hemoglobin antibody that has been sensitized with latex particles, with change in turbidity. This change in turbidity is proportional to the hemoglobin concentration in the specimen. The automatic analyzer is thus capable of quantitatively determining the hemoglobin concentration of the specimen by optical turbidity measurement.

[Procedure]

This reagent is specially designed for use in fully automatic human fecal hemoglobin analyzers. For details, consult the Instruction Manual for the Use of the Fully Automatic Human Fecal Hemoglobin Analyzer. Be sure to carry out the measurements in the temperature range of 20-30°C at constant humidity.

1. Reagent Preparation Method 

(a) Antibody sensitizing latex suspension

Use the antibody sensitizing latex suspension directly after you have restored its temperature to 15-25°C . Immediately before use, turn upside down to mix and obtain a homogenous suspension. After use, store at 2-8°C immediately.

(b) Hemoglobin buffer

Use the hemoglobin buffer directly after you have restored its temperature to 15-25°C . After use, store at 2-8°C immediately.

2. Sample Preparation

For fecal sampling, use the stool sampler in accordance with the Instructions for Use of Stool Sampler included in the sampler package. Use the sample for testing after the stool sampler with the fecal sample has regained ambient temperature (15-25°C).

3. Establishing of calibration curve

(a) Enter the master curve in accordance with the master curve card attached to the kit whenever the lot number of the Exter^® HEMO AUTO antibody sensitizing latex suspension changes.

(b) When the lot number changes or at least once every 2 days, calibrate the master curve with the standard.

Use the Hemoglobin Standard for Fecal Occult Blood Hemoglobin Assay as the standard.

4. Assay Procedure

(a) Input the assay menu into the Fully Automatic Human Fecal Hemoglobin Analyzer.

(b) Place the specimen on the sample table and the reagent in the prescribed location.

Note: Place the sampler directly in such a manner that the bottom of the sampler container faces upward.

(c) After you have depressed the START key enter the Table No. and press ENTER to execute. The entire process from sampling the specimen to the processing of the data after measurement is fully automated.

(Standard Procedure)

[Cautions for Test Procedure]

Properties of sample and sampling methods

Use the Extel^® HEMO AUTO Sampler I, II, S as the sampler that is sold separately.

Use fresh stool.

Carry out the tests immediately after defecation.

If the fecal sample has to be stored, be sure to store in a dark and cool place at 10°C or less (e.g., in a refrigerator).

If stool is hard, moisten with water to sample.

Interfering substances

This reagent shows almost no reaction with hemoglobin derived from animals fed on a normal diet.

It is not susceptible to the influence of foods with peroxidase-like activity and of reducing substances such as ascorbic acid.

Miscellaneous

Use the antibody sensitizing latex suspension after you have properly homogenized the suspension by turning it upside down before use.

Shake the stool sampler after fecal sampling and use the specimen after it has been thoroughly suspended.

* [Assessment of Results]

It is recommended that the standard value for assessing the measurement results be determined by each facility.

For clinical diagnosis based on the assay results, the physician in charge should assess the data in a comprehensive manner in conjunction with the clinical symptoms and the results obtained from other tests.

Assessment standard for reference

30μg/g of stool (12ng/mL) or less ⁴⁾

[Performance]

Tests were performed at our laboratory facilities in accordance with the specified procedure to determine the sensitivity, specificity, reproducibility and measurement range. The results obtained in these tests were as follows.

1. Sensitivity test

(a) Blank tests with the reagent using physiological saline solution as the specimen were carried out to measure the turbidity changes. The result was 100 or less.

(b) Tests with a standard solution of 10ng/mL hemoglobin were performed and the difference in the turbidity changes against the blank test was 80-450.

2. Specificity test

A sample of known concentration was measured and the result was within ±15% of the known concentration.

3. Coincidence Reproducibility Test

When the same specimen was assayed ten times simultaneously the CV value for the measurement data was 10.0% or less.

4. Measurement range

7 - 800ng/mL (17.5-2000μg/g of stool)

[Method Comparison]

The results obtained with this method and the results obtained with the Company A Method showed the following correlation (Use prepared stool)

Regression formula Y = 0.951X-0.03 (n=55)

Correlation coefficient r = 0.985

Y: Extel^® HEMO AUTO X: Company A. 

[Warnings and Precautions]

Use the Exter^® HEMO AUTO in conjunction with the special fecal sampler.

When handling fecal matter, remember that specimens may, in some cases, be contaminated with HBV, HCV, HIV or bacteria. Be sure therefore to wear gloves when handling the specimens in order to prevent infection.

This product contains sodium azide. When it has entered the eye or mouth or contacted the skin by accident, be sure to take the necessary emergency measures by rinsing with copious running water. If necessary, seek medical treatment and consult a physician.

Sodium azide is used as an antiseptic in this reagent. On contact with lead, it reacts vehemently with formation of highly explosive metal azides. When you discard the reagent be sure therefore to dilute and wash with plenty of water. 

Store the antibody-sensitizing latex suspension at 2 - 8°C. Do not freeze the reagent under any circumstances.

Once you have opened the reagent be sure to close the lid and store by the specified method of storage. Do not use when the shelf life has been exceeded.

Storing the antibody-sensitizing latex suspension for a long time with the container left open may affect the measurement results. Be careful when using the suspension.

Do not mix antibody-sensitizing latex suspensions of different lot numbers in the course of a measurement. Nor add reagent to make up a shortage.

All specimens and all equipment, including the test tubes, that have come into contact with the specimens must be either treated by anyone of the following methods or discarded in accordance with the manual in force at the respective facility for the disposal of infectious medical wastes.

Sterilize under pressure at 121°C in an autoclave for 15 minutes. However, do not autoclave wastes containing sodium hypochlorite solutions.

Immerse in a sodium hypochlorite solution (with an effective chlorine concentration of over 1000ppm) for 1 hour or longer.

Incinerate if wastes are combustible.

Do not use the containers and accessories of this kit for any other purpose.

* [Storage and Shelf Life]

Storage: Store in a dark and cool place (at 2-8°C). Do not freeze under any circumstances.

Shelf life: Use within one year after manufacture (The shelf life is displayed on the bottle label and on the outer carton.

[Packaging Unit]

Product Package size Remarks

Extel^® HEMO AUTO

Antibody-sensitizing latex suspension 18mL x 2 For 400 tests

Extel^® HEMO AUTO

Hemoglobin buffer 250mL

Note: Each product is sold separately. 

Use the separately available Hemoglobin Standard for Fecal Occult Blood Assay as the standard.

For accuracy management, use the separately available HM Control.

[Main References]

Tada M. et al. Clinical Pathology 751, 36, 1988

Fujiyoshi K. et al.: Journal of Japanese Gastroenterological Mass Survey 138,95, 1992

Hojo K.: Clinical Testing 495, 36, 1992

In-house data

** For literature and information, please contact:

Kyowa Medex Co., Ltd.

Scientific & Technical Affairs Department

1-8-10 Harumi, Chuo-ku, Tokyo 104-6004

Toll Free No.: 0120-17-4898