US cortez fecal occult blood rapid test card instructions

Fecal occult blood rapid test card
(United States cortez imported, article number: 13010-1 )
US Cortez China exclusive agent "Shenzhen Kerunda Biological Engineering Co., Ltd." dedicated to serve you


Intended Use <br>This rapid test card can be used for the qualitative detection of hemoglobin in human stool samples; this test is a visual one-step method for the professional to diagnose gastrointestinal bleeding.

Introduction <br> Colorectal cancer is the third most common cancer in the world. Blood loss below 50 ml/d is defined as “fecal occult blood”. The presence of occult blood in human stool samples is often associated with gastrointestinal disease, which may lead to colorectal cancer without proper treatment; traditional guaiac-based methods; insufficient sensitivity and specificity, and pre-experiment dietary restrictions
The Cortez Rapid Test Card uses immunochromatographic sandwich technology, which is more sensitive and specific than traditional methods. The results are simpler. In addition, unlike the guaiac method, the accuracy of this test is not affected by the patient's diet.
Experimental principle <br>This rapid test consists of two parts, a stool collection tube and test equipment; the stool sample is collected into a collection tube containing the sample extraction buffer and then added to the test equipment. When the sample is added to the sample well, It passes through an enzyme conjugate pad coated with colloidal gold anti-human hemoglobin antibody, which moves through the membrane by capillary action and reacts with anti-human hemoglobin antibody coated in the test area, if the human hemoglobin content is 50 ng /ml or higher, a color band will be formed in the test area. If there is no hemoglobin in the sample, the test area remains colorless, and the sample continues to move to the control area coated with goat anti-mouse IgG antibody to capture the gold-labeled abzyme. The color of the joint formed into a pink to purple color indicates that the test operation is correct and the result is effective.
Sample collection and preparation
No. 1 sampling tube
  1. Fecal samples can be collected at any time
  2. Randomly collect a stool sample to a clean, dry container
  3. Unscrew the cap of the collection tube (red end) and remove the coating rod
  4. Insert the stick into the different parts of the stool sample
  5. Then put the coating bar back into the collection tube and carefully close the cap. This tube mouth only allows the coating rod to pass through, preventing additional samples from entering the tube.
  6. Grab the cap and shake vigorously for 5 seconds to allow the stool sample to be released and dispersed into the collection buffer.

No. 2 sampling tube
  1. Samples can be collected at any time
  2. Randomly collect a stool sample to a clean, dry container
  3. Unscrew the cap of the collection tube (red end) and remove the coating rod
  4. Insert the stick into the different parts of the stool sample
  5. Then put the coating bar back into the collection tube and carefully close the cap. This tube mouth only allows the coating rod to pass through, preventing additional samples from entering the tube.
  6. Grab the cap and shake vigorously for 5 seconds to allow the stool sample to be released and dispersed into the collection buffer.


Sample stability <br>If the sample is not detected immediately after collection, it can be stored at room temperature (8-30 °C) for 7 days. If conditions permit, the sample can be stored in the refrigerator (2-8 °C) for better storage.
Kit composition
  1. Rapid test card test equipment:
Test area: containing mouse monoclonal antibody anti-hemoglobin antibody QC: containing goat anti-mouse IgG antibody Enzyme conjugate pad: containing sheep-mouse monoclonal antibody anti-hemoglobin antibody enzyme conjugate
  1. Fecal sample collection tube
2ml buffer containing pH 7.6 in the collection tube
  1. user's Guide

Materials required for the experiment but the kit does not provide a timer
Patient preparation
  1. Patients who are not suitable for sampling or suffering from hemorrhoids or urine with blood for 3 days or less are not suitable for sampling.
  2. Excessive use of alcohol, aspirin and other drugs may cause gastrointestinal irritations leading to occult blood; stop using the above substances for at least 48 hours before the experiment
  3. No dietary restrictions

Experimental procedure
  1. Balance all materials and samples to room temperature (8-30 ° C)
  2. Remove the test card from the sealed aluminum foil bag
  3. If the sampling tube No. 1 is used, remove the protective cover (green) from the tip and hold it vertically. Do not aim the operator at the direction of the tip of the gun.
If the No. 2 sampling tube is used, hold it vertically, and the direction of the tip of the gun avoids the operator and breaks the gun head.
  1. The sampling tube is perpendicular to the sample hole, and 3 drops of the sample are added to the sample hole labeled "S" on the test card.
  2. 3-10 readings
Note: Results after 10 minutes may not be accurate
result
Positive : If two color bands appear within 3 minutes, the result is positive and effective. Note: If the sample contains low hemoglobin content, it may take 10 minutes for the two color bands to appear.
Negative : If there is no color band in the test area and there is a color band in the quality control area, the test result is negative and effective.
Invalid result : If there is no color band in the quality control area, the test result is invalid; the sample needs to be retested.


Performance
Sensitivity <br>Test analysis sensitivity 50ng/ml human hemoglobin or 12.5 ug human hemoglobin / g stool
Specificity <br>This test is specific to human hemoglobin. The sample contains the following substances, which have no effect on the test results.

Interference test <br>The following substances are added to human hemoglobin and 50 ng/ml quality control, and the following concentrations will not interfere with the test.

QC
  1. It is recommended to test a human serum protein concentration of 50-200 ng/ml for positive control and 0 ng/ml for negative control, but not available in the kit, available on the market.
  2. The quality control tape is the quality control of the internal reagents and procedures. If the test operation is correct and the reagents are reactive, the quality control tape will appear.
QC can be developed according to local, national and federal regulations

Operational restrictions
  1. The conditions mentioned in "Patient Preparation" may lead to false positive results
  2. All Cortez trials cannot be used solely as a basis for clinical diagnosis. The physician evaluates the results based on all clinical and experimental diagnostic results.

Precautions
  1. For in vitro diagnostic use only
  2. Do not use expired reagents
  3. Treat all samples as potentially infectious materials
  4. The test equipment is packed into the original sealed bag, and the sample is stored in a sampling tube of 4-30 ° C, which cannot be frozen.
  5. The expiration date is established under normal storage conditions.
  6. The test equipment should be stored consistently in the sealed bag until use
  7. The test equipment is designed to be single. Once the sealed bag is opened, it should be tested as soon as possible and cannot be reused.




This translation is for reference only, please refer to the original manual.
Exclusive distributor in China: Shenzhen Kerunda Bioengineering Co., Ltd.
Office Address : 7D, Jialitai Building, No. 45 Yanshan Road, Shekou, Nanshan District, Shenzhen.
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