ALFIS-3 Resources

Results in 15 minutes

Nasal swab with minimum discomfort

For use with or without symptoms

At home test for adults and kids aged 2 years and above

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;

·This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,

·The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro

diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

·For more information on EUAs please visit:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization

·For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

Swab-N-Go Home test COVID-19 Ag 2T (Cat. #: CFPT-17)

Kit Includes:

• Have a watch or timer ready (nor included in the kit)

• Avaliable for bulk purchase. For further details, please contact us using the information provided below

• Quick Reference Instruction

• Package Insert (Home Use)

• Fact Sheet

• Sell Sheet

• SDS

• Package Insert (Health Care Provider)

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.

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.

Yes. AFIAS-1 is a semi-automatic immunodiagnostic device that automatically mixes and dispenses samples when user loads sample only.

C-tip is an special tip with a capillary shape at the end. It is possible to measure some specific markers such as HbA1c, PCT, TSH, CRP and total b-hCG easily with AFIAS readers by fingertip sampling.

No. After inserting the ID Chip once for a specific lot, it is not necessary to insert the ID Chip continuously because the AFIAS readers store the corresponding ID Chip information.

The SD card slot is located on the bottom of the product. Please be sure to leave the tip waste box empty before use.

Once a day is recommended.

Yes. Whole blood is usable for specific items.

Yes. LCD touchscreen of ichroma™ II is pressure sensitive so, you may use ichroma™ II without taking off gloves.

Compared to ichroma™ reader, user convenience (LCD touch screen, built-in printer, etc.) has been improved and Optical technology enabling high sensitivity test including infection marker is applied.

The ALFIS-3 features internal temperature control. That will detect when analyzer is at the needed operational temperature range.

The probable causes may be: poor connection between the power adapter and power cable; analyzer is set to 'Off'; faulty power adapter; power failure; ALFIS-3 is in 'Sleep Mode'.

This can be due to a mechanical error or software malfunction. Restart the ALFIS-3 analyzer, by turning the power 'off' and then, 'on' again.

This is a normal function of the ALFIS-3 analyzer. No action is required.

This could be due to electrostatic shock or an electrical circuit failure. Connect the power cable to a grounded external power outlet and remove any source of electrostatic charge. Restart the analyzer.

This may be due to foreign matter obscuring the barcode or a misprinted barcode. Remove any foreign matter present on the barcode and reinsert the cartridge. If the error code persists, it may be due to a misprinted barcode. Repeat test using a new ALFIS-3 test cartridge.

There is a pipette tip and/or mag tip missing from the test cartridge inserted into the ALFIS-3 analyzer. Eject cartridge and place missing tip(s) in corresponding slot(s). Restart test.

The system temperature is outside the operational temperature range or there is a malfunction of the built-in temperature sensor. Wait 3 minutes and recheck the temperature status of the system. (Refer to section '9.4: Temperature' of the manual)

The test is being performed without an ID Chip or the lot numbers of the ID Chip and test cartridge do not match. Insert ID Chip with matching lot number to the test cartridge being used.

This indicates problems in the Optical System. Contact Immunostics Technical Support.

The printer function may be set to 'off'. Turn the printer 'on' by accessing the 'Printer On/Off' menu. If issue persists, there may be a malfunction in the printer.

The IRIS-3 features internal temperature control.

No. Six different items can be tested simultaneously.

C-tip is an special tip with a capillary shape at the end. It is possible to measure some specific markers such as HbA1c, PCT, TSH, CRP and total b-hCG easily with AFIAS readers by fingertip sampling.

Yes. AFIAS-6 is a semi-automatic immunodiagnostic device that automatically mixes and dispenses samples when user loads sample only.

No. After inserting the ID Chip once for a specific lot, it is not necessary to insert the ID Chip continuously because the AFIAS readers store the corresponding ID Chip information.

Yes. AFIAS-1 is a semi-automatic immunodiagnostic device that automatically mixes and dispenses samples when user loads sample only.

C-tip is an special tip with a capillary shape at the end. It is possible to measure some specific markers such as HbA1c, PCT, TSH, CRP and total b-hCG easily with AFIAS readers by fingertip sampling.

No. After inserting the ID Chip once for a specific lot, it is not necessary to insert the ID Chip continuously because the AFIAS readers store the corresponding ID Chip information.

The SD card slot is located on the bottom of the product. Please be sure to leave the tip waste box empty before use.

Once a day is recommended.

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.

Yes. The estimation of hematocrit, as a function, is only measured for normal hemoglobin values, 12.0 - 18.0 g/dL and in patients older than 6 months old. If the hemoglobin value is outside that range, the hematocrit value will not be estimated.

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 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.