Question 1

Benefits

Accepted Answer

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

Question 2

Product specification

Accepted Answer

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

Question 3

Ordering information

Accepted Answer

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

Question 4

Product Documentation

Accepted Answer

Quick Reference Instruction 
Package Insert (Home Use) 
Fact Sheet 
Sell Sheet 
SDS 
Package Insert (Health Care Provider)

Question 5

Can I measure using examinee’s fingertips?

Accepted Answer

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

Question 6

Do I have to use a battery?

Accepted Answer

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

Question 7

Is it easy to clean when it is contaminated?

Accepted Answer

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

Question 8

Can I measure using examinee’s fingertips?

Accepted Answer

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

Question 9

Do I have to use a battery?

Accepted Answer

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

Question 10

Is it easy to clean when it is contaminated?

Accepted Answer

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

Question 11

Does sample mixing and dispensing occur automatically?

Accepted Answer

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

Question 12

What is C-tip?

Accepted Answer

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.

Question 13

Do I always need to insert an ID chip when testing?

Accepted Answer

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.

Question 14

Where is the SD card slot positioned?

Accepted Answer

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

Question 15

How often do I need to empty the tip waste box?

Accepted Answer

Once a day is recommended.

Question 16

Can I use whole blood in addition to plasma or serum samples?

Accepted Answer

Yes. Whole blood is usable for specific items.

Question 17

Can I use the touchscreen with latex gloves on?

Accepted Answer

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

Question 18

What is the significant difference from ichroma™ reader?

Accepted Answer

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.

Question 19

What are the storage requirements for ALFIS-3?

Accepted Answer

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

Question 20

Why does the ALFIS-3 not turn on?

Accepted Answer

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'.

Question 21

Why does the cartridge holder not protrude out?

Accepted Answer

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.

Question 22

Why is there a clicking noise when the cartridge holder(s) protrude out?

Accepted Answer

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

Question 23

Why does the LCD display not function properly?

Accepted Answer

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.

Question 24

Why is there a barcode error displayed?

Accepted Answer

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.

Question 25

ALFIS-3 test cartridge. Why is there an 'insert tip' message being displayed?

Accepted Answer

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.

Question 26

Why is 'Please wait until the reader reaches the recommended temperature' being displayed?

Accepted Answer

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)

Question 27

Why is 'Insert ID chip' being displayed?

Accepted Answer

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.

Question 28

Why is 'Error_S1' being displayed?

Accepted Answer

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

Question 29

Why can't I print the test results?

Accepted Answer

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.

Question 30

What are the storage requirements for IRIS-3?

Accepted Answer

The IRIS-3 features internal temperature control.

Question 31

Should I test the same item simultaneously?

Accepted Answer

No. Six different items can be tested simultaneously.

Question 32

What is C-tip?

Accepted Answer

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.

Question 33

Does sample mixing and dispensing occur automatically?

Accepted Answer

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

Question 34

Do I always need to insert an ID chip when testing?

Accepted Answer

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.

Question 35

Does sample mixing and dispensing occur automatically?

Accepted Answer

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

Question 36

What is C-tip?

Accepted Answer

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.

Question 37

Do I always need to insert an ID chip when testing?

Accepted Answer

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.

Question 38

Where is the SD card slot positioned?

Accepted Answer

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

Question 39

How often do I need to empty the tip waste box?

Accepted Answer

Once a day is recommended.

Question 40

Why should patients take this test?

Accepted Answer

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.

Question 41

Can I measure using examinee’s fingertips?

Accepted Answer

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

Question 42

Do I have to use a battery?

Accepted Answer

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

Question 43

Is it easy to clean when it is contaminated?

Accepted Answer

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

Question 44

What does the hemochroma PLUS test detect?

Accepted Answer

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.

Question 45

Is the hematocrit level measured as well?

Accepted Answer

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.

Question 46

Do patients need to go on a special diet before or during collecting the sample?

Accepted Answer

No special pre-testing diet restrictions are required.

Question 47

Does the hemochroma PLUS Test have any medicinal restrictions?

Accepted Answer

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

Question 48

Should we run external controls with this kit?

Accepted Answer

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

Question 49

Can I use a thrid-party control or microcuvettes with the hemochroma PLUS analyzer?

Accepted Answer

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

Question 50

How long does it take to have a result available after performing the test?

Accepted Answer

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

Question 51

What is the measuring range of the test?

Accepted Answer

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

Question 52

What is the shelf-life of the hemochroma PLUS test kits and components?

Accepted Answer

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.

Question 53

How many test results are capable of being stored in the hemochroma PLUS analyzer?

Accepted Answer

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.

Question 54

How often should I clean the microcuvette holder?

Accepted Answer

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.

Question 55

Why should patients take this test?

Accepted Answer

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.

Question 56

Can I measure using examinee’s fingertips?

Accepted Answer

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

Question 57

Do I have to use a battery?

Accepted Answer

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

Question 58

Is it easy to clean when it is contaminated?

Accepted Answer

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

Question 59

What does the hemochroma PLUS test detect?

Accepted Answer

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.

Question 60

Do patients need to go on a special diet before or during collecting the sample?

Accepted Answer

No special pre-testing diet restrictions are required.

Question 61

Does the hemochroma PLUS Test have any medicinal restrictions?

Accepted Answer

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

Question 62

Should we run external controls with this kit?

Accepted Answer

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

Question 63

Can I use a thrid-party control or microcuvettes with the hemochroma PLUS analyzer?

Accepted Answer

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

Question 64

How long does it take to have a result available after performing the test?

Accepted Answer

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

Easy To Use Cassette

Easy To Use Cassette

Take Home Mailer

Take Home Mailer

Buffer Solution

Buffer Solution

Colorectal

Cancer

Screening

Greater sensitivity than traditional guaiac-based methods. Increased specificity to lower GI bleeding makes hema-screen SPECIFIC GOLD an ideal tool for colon cancer screening.

Reliable Performance

Our Innovative Technology Includes:

Ability to screen two specimens using a single cassette

30 Day room temperature stability

Both Physician office or patient take home testing

No diet or drug restrictions

CLIA waived

hema-screen SPECIFIC GOLD Resources

SDS

Videos

hema-screen SPECIFIC Overview

Frequently Asked Questions

Benefits

Product specification

Ordering information

Product Documentation

Can I measure using examinee’s fingertips?

Do I have to use a battery?

Is it easy to clean when it is contaminated?

Can I measure using examinee’s fingertips?

Do I have to use a battery?

Is it easy to clean when it is contaminated?

Does sample mixing and dispensing occur automatically?

What is C-tip?

Do I always need to insert an ID chip when testing?

Where is the SD card slot positioned?

How often do I need to empty the tip waste box?

Can I use whole blood in addition to plasma or serum samples?

Can I use the touchscreen with latex gloves on?

What is the significant difference from ichroma™ reader?

What are the storage requirements for ALFIS-3?

Why does the ALFIS-3 not turn on?

Why does the cartridge holder not protrude out?

Why is there a clicking noise when the cartridge holder(s) protrude out?

Why does the LCD display not function properly?

Why is there a barcode error displayed?

ALFIS-3 test cartridge. Why is there an 'insert tip' message being displayed?

Why is 'Please wait until the reader reaches the recommended temperature' being displayed?

Why is 'Insert ID chip' being displayed?

Why is 'Error_S1' being displayed?

Why can't I print the test results?

What are the storage requirements for IRIS-3?

Should I test the same item simultaneously?

What is C-tip?

Does sample mixing and dispensing occur automatically?

Do I always need to insert an ID chip when testing?

Does sample mixing and dispensing occur automatically?

What is C-tip?

Do I always need to insert an ID chip when testing?

Where is the SD card slot positioned?

How often do I need to empty the tip waste box?

Why should patients take this test?

Can I measure using examinee’s fingertips?

Do I have to use a battery?

Is it easy to clean when it is contaminated?

What does the hemochroma PLUS test detect?

Is the hematocrit level measured as well?

Do patients need to go on a special diet before or during collecting the sample?

Does the hemochroma PLUS Test have any medicinal restrictions?

Should we run external controls with this kit?

Can I use a thrid-party control or microcuvettes with the hemochroma PLUS analyzer?

How long does it take to have a result available after performing the test?

What is the measuring range of the test?

What is the shelf-life of the hemochroma PLUS test kits and components?

How many test results are capable of being stored in the hemochroma PLUS analyzer?

How often should I clean the microcuvette holder?

Why should patients take this test?

Can I measure using examinee’s fingertips?

Do I have to use a battery?

Is it easy to clean when it is contaminated?

What is the shelf life of the hema-screen SPECIFIC (HSSP-25 & HSSPCAS-25) test kits?