Immunochemical Fecal Occult Blood Strip Test Kit
rapid
适用: 人
Fecal
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- 抗原
- Occult Blood
- 适用
- 人
- 应用范围
- Rapid Test (rapid)
- 原理
- This EpiTuub? Fecal Occult Blood (FOB) Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. This FOB test device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.
- 样品类型
- Fecal
- 特异性
- This FOB test is specific for the detection of h-Hb, h- Hb-S, h-Hb-C, from whole human blood at a concentration of 50 ng/mL and 100,000 ng/mL.
- 交叉反应 （详细）
- This FOB test does not detect hemoglobin from a cow, horse, pig, fish, chicken, or rabbit.
- 组件
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1. iFOB Test Strip,
2. Fecal Sample Extraction Buffer,
3. Instruction for use 1 - 试剂未包括
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1. Disposable pipette for watery sample collection
2. Plastic or glass test tube (13x75 mm or similar size)
3. 10 µL inoculating loop
4. Positive Control Both are for internal quality control use only.
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Occult Blood ELISA Kit
适用: 人 Colorimetric Sandwich ELISA 0.5-745 ng/mL Fecal
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- 实验时间
- 0.5 h
- 实验流程
- The EpiTuubTMFOB test is a sandwich immunoassay utilizing two monoclonal antibodies to specifically detect the presence of human hemoglobin (h-Hb) in feces. It consists of two units, a fecal sampling device and a test strip. A stool specimen is collected into the sampling tube containing extraction solution. After mixing the stool sample, a test strip is screwed into the sampling tube by breaking the bottom seal of the sampling tube while maintaining a vertical position. The extracted fecal solution flows into the bottom space of the test strip and triggers the start of the FOB immunoassay. If human hemoglobin is present at a level of greater than 50 ng/mL in a fecal sample extract, an immuno-complex of ?labeled monoclonal anti-human hemoglobin antibody ? human hemoglobin ? membrane coated monoclonal antihuman hemoglobin antibody? is formed. A red colored band appears in the test region, which is located in the lower half of the test membrane. a similar colored band must appear in the control region located in the upper-half of the test membrane, indicating the test strip is functioning properly and the result is valid.
- 样品收集
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1. Stool specimens can be collected at any time of the day.
2. Collect a random sample of feces in a clean, dry cup or toilet paper or as indicated in the figure 1.
3. Unscrew the sampling lid and keep the sampling tube in a vertical position to prevent the loss of any extraction solution.
4. Insert and twist the tip of the sampling lid into the stool specimen at two or more different sites (figure 2).
5. Collect fecal sample that is stuck to the surface of the sampling lid. Do not intentionally collect any separate and large pieces of fecal sample into the tube.
6. Replace the sampling lid into the tube and secure tightly (figure 3).
7. The specimen is ready for testing, transportation or storage. It can be stored at 2-8 °C for up to 14 days and at room temperature for up to 5 days. Note: Two specimens from three consecutive bowel movements are recommended from American Cancer Society. Specimen should not be collected during digital rectal examination. - 样品制备
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- Specimen should not be collected during or within three days of a menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
2. Alcohol, aspirin, indomethacin, reserpin, phenylbutazone, corticosteroids and other medications may cause gastrointestinal irritation resulting in occult bleeding. With the physicians approval, such medication should be discontinued for 7 days before and throughout the test period. Rectal medication should be discontinued.
3. Dietary restrictions are not necessary.
- Specimen should not be collected during or within three days of a menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
- 实验流程
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- Bring the sealed foil pouch test strips and collected specimens to room temperature. 2. Shake the sampling tube vigorously to ensure a good liquid suspension. 3. Position the sampling tube upside down vertically and let it settle for about 1 minute. 4. Remove the test strip from the sealed foil pouch. 5. Screw the test strip in a vertical position into the sampling tube by breaking the bottom seal of the sampling tube. Secure tightly! (Figure A) 6. Allow the solution to flow into the bottom space of the test strip and keeping the device in a vertical position. 7. Read test result at 5 minutes. Do not interpret test result after 10 minutes.
- 结果分析
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- Positive: If two colored bands are visible within 10 minutes, the test result is positive and valid (Figure B).
2. Negative: If test area has no colored band and the control area displays a colored band, the test result is negative (Figure B).
3. Invalid: If a colored band does not form in the control area regardless of there being any band in the test area, the test result is invalid (Figure B).
QUALITY CONTROL Good laboratory practices recommend the use of appropriate controls. There are two types of controls for the EpiTuubTM FOB test, the internal procedural control and external controls.
1. Internal procedural control: Each EpiTuubTM FOB test consists a built in procedural control. It will appear if the test has been performed correctly, sample wicking has occurred and the reagents are reactive. It does not ensure that the test line antibody is accurately detecting the presence or absence of occult blood in the test fecal sample.
2. External controls: It is recommended to use external positive controls. The external positive controls are not provided with this kit, but are commercially available from Epitope Diagnostics. External controls are used to assure that the test line antibody is reactive. However, external controls will not detect an error in performing the patient sample test procedure. It is recommended that the external control be tested once per kit. Follow local, state, and federal guidelines for running quality control.
- Positive: If two colored bands are visible within 10 minutes, the test result is positive and valid (Figure B).
- 限制
- 仅限研究用
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- 注意事项
- 1. For in-vitro diagnostic use only. Not to be taken internally. 2. Do not use product beyond the expiration date. 3. Handle all specimens as potentially infectious. 4. Do not reuse the test.
- 储存条件
- 4 °C
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- 抗原
- Occult Blood
- 背景
- Colorectal cancer is the third most common cancer in the world. The appearance of fecal occult blood is often the first, if not the only, indicator associated with colorectal cancer and polyps. Other gastrointestinal disorders such as diverticulitis, Crohn?s disease, colitis ulcer, etc. may also be associated with the presence of fecal occult blood. There are two different types of FOB tests available, the traditional guaiac FOB test and antibody based immunological FOB test. The traditional guaiac FOB tests do not provide a high degree of accuracy. Immunological FOB tests are more accurate and do not require special dietary restrictions prior to the test sample collection.
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