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.