hemoCARE 005031-E 3 Hole Slide Test For Fecal Occult Blood Instructions
- June 15, 2024
- hemoCARE
Table of Contents
hem0care 005031-E 3 Hole Slide Test For Fecal Occult Blood Instructions
Product Information
Specifications
- Method : Modified guaiac test according to Greegor
- Readings : 30 seconds to 2 minutes after application of the developer solution onto each dried fecal specimen
- Evaluation : Any trace of blue colour development detectable 30 seconds to 2 minutes after application of the developer solution onto the dried fecal specimen is judged as a positive test for fecal occult blood
- Specimen : Stool
- Reagents :
- Natural guaiac resin impregnated into standardized, high-quality filter paper
- Active reagent: cum guaiac; min. 0.05 mg per test
- Developer Solution: Hydrogen peroxide in ethyl alcohol
- Active reagent: H2O2; 0.69 g/20 ml
Storage:
The bottles with developer solution should always be tightly capped to prevent
evaporation. The developer solution is highly flammable and can cause skin
irritation and serious eye irritation.
Product Usage Instructions
Evaluation by the Physician:
- Open the lid at the back of the test slide (To be opened by physician only)
- Apply 1 to 2 drops of hemoCARE developer solution directly onto the dried fecal specimens in the guaiac-impregnated testing areas.
- Read results after 30 seconds to 2 minutes.
- Each trace of blue colour development in or around a stool specimen is judged as a positive test result for fecal occult blood. The reason for intestinal bleeding should be diagnosed accordingly.
- The absence of a blue colour change is judged as a negative test result for fecal occult blood in stool.
Test Principle:
The test is based on the modified guaiac test according to Greegor. It
involves applying the hemoCARE developer solution onto dried fecal specimens
and evaluating the presence or absence of blue color development within 30
seconds to 2 minutes. Positive test results indicate the presence of fecal
occult blood, which may be a sign of intestinal bleeding.
Preparation of the Patient:
For an initial screening, special preparation of the patient is generally
not necessary. However, the following dietary restrictions recommended in
colon cancer screening programs should be considered and followed 3 days prior
up to the end of specimen collection.
Provide the patient with an envelope containing 3 test slides, 9 cardboard applicators for taking the fecal specimen, and 1 patient information sheet.
Preparation of the Test Slide:
- Write the date of specimen collection and the patient’s name and address on the back of the slide.
- The patient opens the test slide at the front side (patient – open here) and takes a pea-sized sample of the stool with a cardboard applicator. Spread the sample onto the left field A.
- Using a new cardboard applicator, take another sample from a different location of the stool specimen and smear it onto field B.
- Repeat step 3 with a new cardboard applicator, taking a third sample from yet another location in the same stool specimen and smear it on the right field C. Close the lid of the test slide. The slide must always be protected from light and heat.
- Follow the same procedure for the second and third test slides over the next two days or after the next two bowel movements.
- After completing the third test slide, put all the test slides into the envelope and return them to the physician or laboratory as soon as possible.
Specimen :
Gastrointestinal lesions may bleed heavily or only intermittently, affecting
the chances of detecting fecal occult blood.
FAQ (Frequently Asked Questions)
How long should I wait before reading the test results?
You should read the test results between 30 seconds to 2 minutes after
applying the hemoCARE developer solution onto the dried fecal specimens.
What does a positive test result indicate?
Any trace of blue colour development detectable within 30 seconds to 2
minutes after applying the developer solution onto the dried fecal specimen is
considered a positive test result for fecal occult blood. Further diagnosis is
required to determine the reason for intestinal bleeding.
How should I store the developer solution?
The bottles containing the developer solution should always be tightly
capped to prevent evaporation. Additionally, keep them away from heat and
light.
Instructions for use for the physician
3-hole Slide Test for fecal occult blood
SUMMARY
- Method : modified guaiac test according to Greegor
- Readings : 30 seconds to 2 minutes after application of the developer solution onto each dried fecal specimen
- Evaluation : Any trace of blue colour development detectable 30 seconds to 2 minutes after application of the developer solution onto the dried fecal specimen is to be judged a positive test for fecal occult blood.
- Specimen : stool
REAGENTS
Natural guaiac resin is impregnated into standardized, high-quality filter
paper.
Active reagent :
cum guaiac; min. 0.05 mg per test.
Developer Solution:
Hydrogen peroxide in ethyl alcohol.
Active reagent : H2O2; 0.69 g/20 ml.
Keep bottles with developer solution capped tightly always. The developer
solution evaporates quickly.
Hazard and Precautionary statements:
- H225 : highly flammable liquid.
- H315 : causes skin irritation.
- H319 : causes serious eye irritation.
- P102 : Keep out of reach of children.
- P233 : Keep the container tightly closed.
- P210 : Keep away from heat – no smoking.
- P264 : Wash hands thoroughly after handling.
- P280 : Wear protective gloves/eye protection.
- P313 : Get medical advice/attention.
STORAGE
Store hemoCARE test slides and developer solution at 4 – 28 °C (39 – 82 °F)
and protected from light and heat. Do not use after expiration date. The test
slide and the developer solution are ready to be used.
EVALUATION by the PHYSICIAN
- The open the lid at the back of the test slide (“To be opened by physician only”)
- Apply 1 to 2 drops of hemoCARE developer solution directly onto the dried fecal specimens in the guaiac-impregnated testing areas.
- Read results after 30 seconds to 2 minutes.
Each trace of blue colour development in or around a stool specimen is to be judged a positive test result and accordingly the reason for intestinal bleeding which has to be diagnosed. The absence of a blue colour change is judged a negative test result for fecal occult blood in the stool.
Example:
Attention:
In order to achieve reliable test results be aware of the following general
notes concerning the test slides:
- protect from light and heat
- protect from direct sunlight and UV-radiation
- never read results close to an opened window
TEST PRINCIPLE TEST PRINCIPLE
By applying the hydrogen peroxide contained in the developer solution to the dried fecal specimen on the guaiac-impregnated reaction paper, the guaiac is oxidised by the peroxidase-like action of intact hemoglobin and therefore develops a characteristic blue colour. The test only reacts with the free hemoglobin of destroyed erythrocytes. In the presence of blood, hemolysis is promoted by substances contained in stool, primarily water and salts. hemoCARE is designed for an increased hit rate in the detection of fecal occult blood without having the problem of detecting physiological bleeding.
PREPARATION of the PATIENT
For an initial screening special preparation of the patient is generally not necessary. However, the dietary restrictions given below and recommended in colon cancer screening programs should be considered and followed 3 days prior up to the end of specimen collection.
- Eat food rich in roughage (vegetables, salads, whole grain bread, nuts) to reveal silent lesions.
- Do not eat raw or rare meat or sausages, because food containing blood could give positive results, even though there is no intestinal bleeding.
- Do not take iron pills or the like because high iron concentrations may result in false-positive test results. Please also keep this in mind in the case of multivitamins- or iron pills.
- Do not take medication rich in ascorbic acid (Vitamin C) because in rare cases (more than 1 g ascorbic acid per day) it might result in false-negative results.
Give the patient an envelope containing 3 test slides, 9 cardboard applicators (for taking the fecal specimen) and 1 patient information sheet.
PREPARATION of the TEST SLIDE
- The date of specimen collection and the patient’s name and address are to be written on the back of the slide.
- The patient opens the test slide at the front side (“patient – open here”). A pea-sized sample of the stool is taken with a cardboard applicator and is spread onto the left field “A”.
- With a new cardboard applicator, another sample is taken from a different location of the stool specimen and is smeared onto field “B”.
- Again, with a new cardboard applicator a third sample from yet another location in the same stool specimen is taken and smeared on the right field “C” and the lid of the test slide is closed. The slide must always be protected from light and heat.
- The same procedure is to be followed for the second and the third test slides during the next two days or after the next two bowel movements. After completing the third test slide, all the test slides are put into the envelope and should be returned to the physician or laboratory as soon as possible.
SPECIMEN
For the preparation of the test slide, a pea-sized stool sample is
necessary to be smeared within the test field. The test slides can be
evaluated only after the stool samples have dried. Moist stool samples will
result in decreased test sensitivity, as with stool samples that were
collected more than 12 days ago. Hands, gloves and the working area should be
free from blood. Some stool samples might show blood due to hemorrhoids or
menstrual bleeding for example – such samples are not suitable for a reliable
diagnosis.
Notes:
- Gastro intestinal lesions may bleed heavily or only intermittently.
- positive test must not be repeated in order to double-check a test result.
- negative test result does not rule out a carcinoma. In case of reasonable suspicion or stomach problems, another diagnosis is necessary.
- it is recommended to take samples from 3 different bowel movements and to take the 3 samples of different portions of the stool from each bowel movement In order to increase the chances of detecting fecal occult blood.
- In the event hemorrhoids are detected after a positive test result, the test should be repeated after treatment and healing of the hemorrhoids. Positive test results may also arise due to another colon bleeding.
- The intake of medicines like aspirin, indomethacin, phenylbutazone, corticosteroids, reserpine and the like may cause gastro-intestinal irritations or bleeding. Whether or not the intake of such medication can be paused for the duration of the test phase should be evaluated.
- High iron concentrations, as in the case of iron therapies may cause false-positive results. A sample containing ~100 mg Iron+3-Chloride within 100 g of stool sample results in a clear blue color reaction of the test field. Therefore it is highly recommended to pause such therapies before and during the testing period.
- In rare cases, the intake of vitamin-C medication (> 1 g ascorbic acid per day) may cause false-negative results due to the reducing action of ascorbic acid. Therefore vitamin C medication should be paused before and during the testing period.
SYMBOLS
- In-vitro diagnostic device“
- Read instructions carefully before using “
- Use only once“
- Order number“
- Expiration date“
- LOT number“
- CE Symbol“
REF 005031-E (box containing 25×3, 50×3 or 500×3 tests) 25 / 50 / 500 envelopes, each with 3 hemoCARE test slides 9 cardboard applicators patient information sheets
REF 003630-E (25 tests)
Immunological detection of fecal occult blood
- 25 foil pouches with test cassette and desiccant
- 25 sample collection tubes with sample buffer and patient label
- 25 patient information sheets
- 25 plastic pouches
Manufacturer and International Distribution:
CARE diagnostics
[email protected],
www.carediagnostica.com
References
- Take CARE - Wir übernehmen Verantwortung | Care Diagnostica
- hemoCARE Guaiac Test | Praxisdienst Online