Document No.

: INS-CV-EN
Revision date : October 07, 2021 (Rev. 07)

which has recombinant HCV antigen at the test line and

chicken IgY at the control line. All cartridges are
individually sealed in an aluminum foil pouch containing a
desiccant in a box.

Anti-HCV
The detector tube has a granule containing HCV antigen-
fluorescence conjugate, anti-chicken IgY-fluorescence
conjugate and bovine serum albumin (BSA) as a stabilizer
in phosphate buffered saline (PBS). All detector tubes are
INTENDED USE packed in a pouch.
The detector diluent contains sodium chloride and bovine
ichroma™ Anti-HCV is a fluorescence Immunoassay (FIA) serum albumin (BSA) as a stabilizer and sodium azide as a
for the qualitative determination of antibody to Hepatitis preservative in phosphate buffered saline (PBS) and it is
surface antigen (Anti-HCV) in human whole pre-dispensed in a vial. The detector diluent is packed in a
blood/serum/plasma. It is useful as an aid to diagnosis of box.
Hepatitis C virus infection.
For in vitro diagnostic use only. WARNINGS AND PRECAUTIONS

INTRODUCTION For in vitro diagnostic use only.

Follow instructions and procedures described in this
Hepatitis C virus (HCV) infection is a worldwide public ‘Instruction for use’.
health problem with a global prevalence of 2-3%. It is Use only fresh samples and avoid direct sunlight.
believed that about 170 million people are currently infected Lot numbers of all the test components (cartridge,
(about 3% of the world's population), and a further 3-4 detector tube, detector diluent and ID chip) must match
million are infected each year. HCV is a frequent cause of each other.
chronic liver diseases such as hepatitis. HCV is the main Do not interchange the test components between
reason for liver transplantation in the developed world and, different lots or use the test components after the
it is primarily transmitted via blood.1)2) After 1-3 weeks of expiration date, either of which might yield incorrect test
acute HCV infection, HCV RNA becomes detectable in blood result(s).
and rapidly increases. Most infection is asymptomatic (70- Do not reuse cartridges or detector tubes. A cartridge
80%) but symptoms including flu-like symptoms, fatigue, should be used for testing one sample only. A detector
vomiting, nausea, right upper quadrant pain, muscle pain, or tube should be used for processing of one sample only.
pruritus may develop within 2-12 weeks. About 50-80% of The cartridge should remain sealed in its original pouch
HCV infected patients progress to chronic infection. Once it until just before use. Do not use the cartridge, if pouch is
becomes chronic hepatitis, it can cause persistent liver injury damaged or has already been opened.
without spontaneous recovery leading to cirrhosis and HCC. Frozen sample should be thawed only once. For shipping,
Most (60-80%) patients with chronic hepatitis show no samples must be packed in accordance with the local
symptoms, but some can experience abdominal discomfort, regulations. Sample with severe hemolytic and/or
fatigue, nausea, muscle pain, arthritis, or weight loss. hyperlipidemia must not be used.
Serologic assays testing are needed to confirm HCV infection. Allow cartridge, detector tube, detector diluent and
Physical examination, treatment and history taking should be sample to be at room temperature for approximately 30
done to understand the routes of transmission and block minutes before use.
further reinfection. Detection of anti-HCV in serum or plasma The instrument for ichroma™ tests may generate slight
is used for screening of a high risk group and for diagnosis of vibration during use.
acute or chronic hepatitis C.3) Used cartridges, detector tubes, detector diluent and
pipette tips should be handled carefully and discarded by
PRINCIPLE an appropriate method in accordance with relevant local
The test uses a sandwich immunodetection method; the regulations.
detector antibodies in buffer bind to antigen in the sample, An exposure to larger quantities of sodium azide may
forming antigen-antibody complexes, and migrate onto cause certain health issues like convulsions, low blood
nitrocellulose matrix to be captured by the other pressure and heart rate, loss of consciousness, lung injury
immobilized-antibodies on test strip. and respiratory failure.
More antibodies in the sample will form more antigen- ichroma™ Anti-HCV will provide accurate and reliable
antibody complexes which lead to stronger fluorescence results subject to the following conditions.
signal by detector antibodies, which is processed by - ichroma™ Anti-HCV should be used only in conjunction
instrument for ichroma tests to display the ‘Positive’ / with instrument for ichroma™ tests.
‘Negative’ / ‘Indeterminate’ in the sample. - Have to use recommended anticoagulant sample.
Recommended anticoagulant
COMPONENTS K2 EDTA, K3 EDTA, EDTA,
ichroma™ Anti-HCV consists of ‘cartridges’, ‘detector tube’ Na-heparin, Li-heparin Sodium Citrate
and ‘detector diluent’.
The cartridge contains the membrane called a test strip
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Document No. : INS-CV-EN
Revision date : October 07, 2021 (Rev. 07)

STORAGE AND STABILITY Samples may be stored for up to a week at 2-8 °C prior to
being tested. If testing will be delayed more than a week,
Storage condition
samples should be frozen at -20 °C.
Storage Shelf
Component
Temperature life
Note Samples stored frozen at -20 °C for 2 months showed no
Cartridge 4- 30 °C 20 months Disposable performance difference.
Detector tube 2-8 °C 20 months Disposable However, the whole blood sample should not be kept in a
Detector diluent 2-8°C 20 months Unopened freezer in any case.
After the cartridge pouch is opened, the test should be Once the sample was frozen, it should be thawed one time
performed immediately. and only for test, because repeated freezing and thawing
can result in the changed test values.
LIMITATION OF THE TEST SYSTEM TEST SETUP
The test may yield false positive result(s) due to the cross- ichroma™ Anti-HCV should be performed at environment
reactions and/or non-specific adhesion of certain sample
components to the capture/detector antigens. temperature 25 ± 3 ℃.
The test may yield false negative result. The non- Check the contents of ichroma™ Anti-HCV: Sealed
responsiveness of the antibodies to the antigens which is Cartridges, Detector tubes, Detect diluents, ID Chip and
the most common if the epitope is masked by some Instruction for use.
unknown components, so therefore not being detected or Ensure that the lot number of the cartridge matches that
captured by the antibodies. The instability or degradation of the detector tubes, detector diluent, ID Chip and an
of the antigen with time and/or temperature may also Instruction for use.
cause false negative results as it makes antigen If the sealed cartridge, the detector tube and the detector
unrecognizable by the antigens. diluent have been stored in a refrigerator, place them on a
Other factors may interfere with the test and cause clean and flat surface at room temperature for at least 30
erroneous results, such as technical/procedural errors, minutes before testing.
degradation of the test components/reagents or presence Turn on the Instrument for ichroma™ tests.
of interfering substances in the test samples. (Please refer to the ‘Instrument for ichroma™ tests
Any clinical diagnosis based on the test result must be Operation Manual’ for complete information and
supported by a comprehensive judgment of the operating instructions.)
concerned physician including clinical symptoms and
other relevant test results. TEST PROCEDURE
<Multi Mode>
MATERIALS SUPPLIED 1) Transfer 150 µL of detector diluent using a pipette to
REF CFPC-31 detector tube containing a granule. When the granule
form is completely dissolved in the tube, it becomes
Components of ichroma™ Anti-HCV
detection buffer.
Cartridge Box:
2) Transfer 30 µL of sample (Human whole
- Cartridge 25
blood/serum/ plasma/control) using a pipette to a
- Detector tube 25
detector tube.
- Detector diluent 1
3) Close the lid of the detector tube and mix the sample
- ID Chip 1
thoroughly by shaking it about 10-20 times. (The
- Instruction for Use 1
sample mixture must be used immediately.)
4) Pipette out 75 μL of a sample mixture and load it into
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND
the sample well on the cartridge.
Following items can be purchased separately from 5) Leave the cartridge at room temperature for 12
ichroma™ Anti-HCV. minutes before inserting the device into the holder.
Please contact our sales division for more information. Scan the sample-loaded cartridge immediately
Instrument for ichroma™ tests when the incubation time is over. If not, it will cause
- ichroma™ II REF FPRR021 inexact test result.
Printer REF FPRR007 6) To scan the sample-loaded cartridge, insert it into the
Boditech Anti-HCV Control REF CFPO-143 cartridge holder of the instrument for ichroma™
tests. Ensure proper orientation of the cartridge
SAMPLE COLLECTION AND PROCESSING before pushing it all the way inside the cartridge
The sample type for ichroma™ Anti-HCV is human whole holder. An arrow has been marked on the cartridge
blood/serum/plasma. especially for this purpose.
It is recommended to test the sample within 24 hours after 7) Tab the ‘Start’ icon on the screen.
collection. 8) The instrument for ichroma™ tests will start scanning
The serum or plasma should be separated from the clot by the sample-loaded cartridge immediately.
centrifugation within 3 hours after the collection of whole 9) Read the test result on the display screen of the
blood. instrument for ichroma™ tests.

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Document No. : INS-CV-EN
Revision date : October 07, 2021 (Rev. 07)

<Single Mode> PERFORMANCE CHARACTERISTICS

1) Transfer 150 µL of detector diluent using a pipette to
Analytical Sensitivity
detector tube containing a granule. When the granule
- Cut-off
form is completely dissolved in the tube, it becomes
ichroma™ Anti-HCV decides between positive and
detection buffer.
negative through COI calculated by ichroma™ II
2) Transfer 30 µL of sample (Human whole
algorism.
blood/serum/ plasma/control) using a pipette to a
Cut-off Index (COI) Result
detector tube.
3) Close the lid of the detector tube and mix the sample COI ≥ 1.0 Positive
thoroughly by shaking it about 10-20 times. (The 0.90 < COI < 1.0 Indeterminate
sample mixture must be used immediately.) COI ≤ 0.90 Negative
4) Pipette out 75 μL of a sample mixture and load it into
the sample well on the cartridge. Analytical Specificity
5) Insert the cartridge into the holder immediately of - Cross-reactivity
the instrument for ichroma™ tests. Ensure proper There was no significant cross-reactivity in the
orientation of the cartridge before pushing it all the ichroma™ Anti-HCV tests with mentioned cross-
way inside the cartridge holder. An arrow is marked reactivity materials.
on the cartridge especially for this purpose. No Cross-reactivity material
6) Tap the “START” button on the instrument for 1 Cytomegalovirus (CMV)
ichroma™ test. 2 Epstein-Barr virus (EBV)
7) Cartridge goes inside the instrument for ichroma™ 3 Hepatitis A virus (HAV)
tests and will automatically start scanning the 4 Anti-HBV
sample-loaded cartridge after 12 minutes. 5 Hepatitis B surface antigen (HBsAg)
8) Read the test result on the display screen of the 6 Herpes simplex virus (HSV)
instrument for ichroma™ tests. 7 Rubella virus
8 Varicella-zoster virus (VZV)
INTERPRETATION OF TEST RESULT 9 Syphilis
10 Anti Nuclear Antibody (ANA)
Instrument for ichroma™ tests calculates the test result
automatically and displays “Positive”/“Negative”/ 11 Rheumatoid factor (RF)
“Indeterminate”. 12 Samples of pregnant women
Ancillary value is served in the form of a cut-off index (COI). - Interference
Cut-off index There was no significant interference from these
Result Note
(COI) material with the ichroma™ Anti-HCV test.
Negative for No need to No. Materials Concentration
≤ 0.90
anti-HCV. additional test. 1 Heparin 100,000 U/L
0.90 < COI < 1.0 Indeterminate. Need to retest. 2 EDTA 2 mg/mL
Need to 3 Sodium citrate 0.15 M
Positive for
≥ 1.0 confirmation 4 Bilirubin 500 μM
anti-HCV.
test. 5 Hemoglobin 2 g/L
6 Triglycerides 37 mmol/L
QUALITY CONTROL
7 Cholesterol 20 mM
Quality control tests are a part of the good testing practice 8 BSA 60 g/L
to confirm the expected results and validity of the assay
and should be performed at regular intervals. Precision
The control tests should be performed immediately after - Between LOT
opening a new test lot to ensure the test performance is One person tested three different lots of ichroma™
not altered. Anti-HCV, ten times at each concentration of the
Quality control tests should also be performed whenever control standard.
there is any question concerning the validity of the test - Between person
results. Three different persons tested same LOT of ichroma™
Control materials are provided on demand with ichroma™ Anti-HCV, five times at each concentration of the
Anti-HCV. For more information regarding obtaining the control standard.
control materials, contact Boditech Med Inc.’s Sales - Between day
Division for assistance. One person tested one LOT of ichroma™ Anti-HCV
(Please refer to the instruction for use of control material.) during three days, five times at each concentration of
the control standard.
- Between site.
One person tested one LOT of ichroma™ Anti-HCV in
three different space, five times at each concentration
양식-GE02-15 (Rev. 04) 3 / 4
Document No. : INS-CV-EN
Revision date : October 07, 2021 (Rev. 07)

of the control standard. For technical assistance; please contact:

Between lot Between person Boditech Med Inc.’s Technical Services
Positive/ Positive/ Tel: +(82) 33 243-1400
Cal
Number Positive rate Number Positive rate E-mail: [email protected]
of tests of tests
Negative 0/30 0% 0/15 0%
Mid 30/30 100% 15/15 100% Boditech Med Incorporated
Low 30/30 100% 15/15 100% 43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398
Republic of Korea
Between day Between site
Tel: +(82) -33-243-1400
Positive Positive
Cal
Fax: +(82) -33-243-9373
/Numbe /Numbe
Positive rate Positive rate www.boditech.co.kr
r of r of
tests tests
Negative 0/15 0% 0/15 0%
High 15/15 100% 15/15 100%
Mid 15/15 100% 15/15 100%
Low 15/15 100% 15/15 100%

Comparability with reference product

Reference product
Positive Negative Total
Positive 96 2 98
ichroma™
Negative 1 425 426
Anti-HCV
Total 97 427 524
- Positive Comparability: 98.97 %
- Negative Comparability: 99.53 %

REFERENCES
1. HCV infection: pathogenesis, clinical manifestations and
therapy. Antonelli A et al., Clin Exp Rheumatol. 2008 Jan-
Feb;26(1 Suppl 48):S39-47
2. Managing occupational risks for hepatitis C transmission
in the health care setting. Henderson DK et al., Clin
Microbiol. Rev. 2003 Jul;16(3):546-68.
3. KASL clinical practice guidelines: management of hepatitis
C. Korean Association for the Study of the Liver(KASL) et
al., Clin Mol Hepatol. 2014; 20(2): 89-136.

Note: Please refer to the table below to identify various

symbols.

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