The measuring range for hemoglobin is: 5.0 – 25.6 g/dL.

The hemochroma PLUS analyzer does not have an expiration date. The hemochroma PLUS Microcuvettes and Optical System Check have a 24-month shelf-life from D.O.M.

The analyzer can store 1000 patient results at a time. The device will begin over-riding the oldest results after the 1001 test has been performed.

The microcuvette holder should be cleaned at the conclusion of patient testing, on days of testing. It can be cleaned with alcohol or a mild soap solution. This is the only maintenance required for the device.

Having symptoms of weakness, dizziness, pale skin and cold hands and feet, Parents or other immediate family members have had a history of any blood disorder, If current diet is very low in iron and mineral content, Suffering from a long-term infection, They have suffered an excessive blood loss due to injury or surgical procedure, They are pregnant.

Yes. In addition to collecting fingertips, venous blood can also be measured by pipetting into a cuvette.

No. You can also use the cable by connecting it to a PC.

Yes. Since the holder for inserting the cuvette is detachable, it can easily be cleaned by inserting alcohol into the swab after detachment.

The hemochroma PLUS test is a quantitative test for the determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood.

No special pre-testing diet restrictions are required.

No typical endogenous and exogenous substances showed there was interference (List of substance tested can be found in the package insert under Performance Characteristics)

Controls are recommended in accordance with local, state and /or federal regulations or accreditation requirements.

No. Use only the hemochroma PLUS Controls and microcuvettes. We can not guarantee compatibility of a third-party item with our system.

Test results are available within 3 seconds once the test has begun.

The measuring range is: 5.0 – 25.6 g/dL.

The hemochroma PLUS analyzer does not have an expiration date. The hemochroma PLUS Microcuvettes and Optical System Check have a 24-month shelf-life from D.O.M.

The analyzer can store 1000 patient results at a time. The device will begin over-riding the oldest results after the 1001 test has been performed.

The microcuvette holder should be cleaned at the conclusion of patient testing, on days of testing. It can be cleaned with alcohol or a mild soap solution. This is the only maintenance required for the device.

hema-screen SPECIFIC, a Fecal Immunochemical Test (FIT), is a rapid, convenient qualitative immunoassay for the determination of human hemoglobin in feces, a vital tool in the diagnosis and therapy of gastrointestinal disorders. Studies show that the following risk factors increase a person's chances of developing colorectal cancer:

• Age: colorectal cancer can occur at younger ages

• Diet (high in fat and calories and low in fiber or high in red or processed meat)

• Obesity; Physical inactivity; Cigarette smoking; Heavy alcohol consumption

• History or familial polyposis (parents, siblings, children

• Persons having ulcerative colitis or crohn’s disease

The hema-screen SPECIFIC iFOB test detects human hemoglobin in stool resulting from lower GI bleeding.

In comparison with guaiac-based testing the hema-screen SPECIFIC test has a higher specificity due to its unique combination of monoclonal and polyclonal antibodies that are specific to human-globin. A traditional guaiac test reacts with the peroxidase activity of heme protein in blood and is non-specific for human hemoglobin.

hema-screen™ SPECIFIC features an innovative sampling method that utilizes one card for collection of two (2) specimens of feces and ONLY one immunochemical specimen preparation tube/test cassette system for analysis. Advantages of utilizing the DEVEL-A-TAB sampler are as follows: thirty (30) days stability; and if the card is not returned the buffer tube and cassette are still useable. In addition, the replacement of the DEVEL-A-TAB sampler and mailing costs are reduced in comparison to the replacement of the buffer tube.

Since hema-screen™ SPECIFIC detects only blood from the lower GI tract where polyps and colorectal cancer develop, the test was found to be more accurate than a leading guaiac-based FOBT. In clinical studies, hema-screen™ SPECIFIC demonstrated a sensitivity of 98% and a specificity of 99%. When compared with a guaiac-based FOBT, hema-screen™ SPECIFIC demonstrated 33% greater sensitivity for occult blood.

There are no dietary restrictions required in order to use the hema-screen SPECIFIC product offering.

There are no dietary restrictions required in order to use the hema-screen SPECIFIC product offering.

There are no medicinal restrictions required in order to use the hema-screen SPECIFIC product offering.

There is no fecal handling involved when performing sample collections. Rather, samples are taken by defecating onto a tissue and using an applicator stick to stab the stool in 4-6 different sites. Once the sample is collected on the applicator lay the DEVEL-A-TAB sampler on a flat surface and apply the sample to window #1 by pulling the applicator stick across the entire window, making sure that the cavity is evenly filled and leveled. Close flap. Release tissue and FLUSH tissue and discard applicator stick.

The test should be read at 5 minutes, after the addition of specimen to the test cassette well. Do not read after the 5-minute read time.

Check that there is not excess specimen in the tube. Use stick attached to tube cap to loosen feces from sample strip if dispersion of specimen seems inadequate. Shake the tube vigorously (or vortex or rotator mix) to ensure the feces is well mixed with the buffer. Some small amount of fecal matter may not go into solution. There should not be any significant amount of undissolved fecal matter in the preparation tube. If the buffer flow along the test cassette appears to have stopped. First, tap cassette lightly on a hard surface, if flow does not continue, dispense one or more further drops into the test cassette well. If the test continues to not develop the patient should be supplied another collection kit and instructed to perform sample collection in accordance with the instructions for use. If there is no excess specimen and the test still does not develop within 5 minutes after the application of 2 additional drops of buffer, please contact Technical Services, Immunostics, Inc. in the US: 1-800-722-7505.

hema-screen SPECIFIC detects human blood in stool. There are many gastrointestinal conditions that may cause blood in stool, aside from colorectal cancer. If a patient receives a positive test result, more testing and evaluation is necessary and the American Cancer Society recommends follow-up with a colonoscopy.

Higher accuracy is achieved when testing is performed on two (2) consecutive fecal samples due to intermittent bleeding. The hema-screen SPECIFIC kit (Cat. №: HSSP-25) meets the American Cancer Society and the U.S. Task Force for Colorectal Cancer (CRC) Foundation recommendation of multiple-day testing.

50 ng hHb/mL buffer or 50 µg hHb/g feces.

24-months from the date of manufacture. The kits can be stored up to room temperature (4-30°C).

The collected fecal sample can be stored for up to 30 days at room temperature when utilizing our patented DEVEL-A-TAB system (HSSP-25) or up to 14 days at 2-8°C in the specimen preparation tube.

Yes, if blood is visible in stool or urine.

No. The test should not be performed three days prior to, during, and 3 days after a patient’s menstrual period. Also, hemorrhoids may interfere with test results. Testing may be performed after bleeding ceases.

Conditions such as ulcerative colitis or certain types of relapsing infectious diarrhea can vary in severity over time, and FOBT may assist in assessing the severity of the disease.

Phosphate Buffer Solution (PBS).

No.

Yes, the collection paper is biodegradable and can be flushed in the toilet.

Dilution of specimen, due to contact with urine or water from the toilet bowl, may render erroneous test results.