Document No.

: INS-DG_E-EN
Revision date : May 19, 2022 (Rev. 02)

cartridges are individually sealed in an aluminum foil

pouch containing a desiccant, and they are further
packaged in a box.
 The detector tube has a granule containing Dengue
antigen-fluorescent conjugate, anti-chicken IgY
fluorescent conjugate, bovine serum albumin (BSA) as a
Dengue IgG/IgM 
stabilizer in Tris. All detector tubes are packed in a pouch.
The detector diluent contains sodium azide as a
preservative in Tris, and it is pre-dispensed in a vial. The
INTENDED USE detector diluent is packed in a box.

ichroma™ Dengue IgG/IgM is a fluorescence WARNINGS AND PRECAUTIONS

immunoassay (FIA) for the qualitative determination of
 For in vitro diagnostic use only.
IgG/IgM antibodies against dengue virus in human whole
 Follow instructions and procedures described in this
blood/serum/plasma. It is useful as an aid in screening of ‘Instructions for use’.
Dengue virus infection.
 Use only fresh samples and avoid direct sunlight.
For in vitro diagnostic use only.  Lot numbers of all the test components (cartridge,
detector tube, detector diluent, and ID chip) must match
INTRODUCTION
each other.
Dengue virus (DENV), a mosquito-borne virus,  Do not interchange the test components between
phylogenetically belongs to the genus Flavivirus, including different lots or use the test components after the
Zika virus, West Nile virus, yellow fever virus, and Japanese expiration date, either of which might yield incorrect test
encephalitis virus. Dengue virus comprises of 4 serotypes result(s).
distinct in the infection tendency and immune responses.  Do not reuse cartridges or detector tubes. A cartridge
Dengue virus infection causes clinically a wide range of should be used for testing one sample only. A detector
human diseases from mild Dengue Fever (DF) to severe tube should be used for processing of one sample only.
Dengue Hemorrhagic Fever (DHF) or Dengue Shock  The cartridge should remain sealed in its original pouch
Syndrome (DSS).1) Several lines of evidences show that until just before use. Do not use cartridge, if pouch is
secondary Dengue virus infection, with different serotypes damaged or has already been opened.
from the primary infection, is relevant to severe Dengue  Frozen sample should be thawed only once. For shipping,
diseases.2) The immune response to primary or secondary samples must be packed in accordance with local
virus infection varies. In the case of primary infection, regulations. Sample with severe hemolysis and/or
specific IgM is higher titre during 4-10 days after onset of hyperlipidemia must not be used.
illness than IgG. IgG response become permanent for whole  If test components and/or sample are stored in
life of patient with primary infection. During secondary refrigerator, then allow cartridge, diluent and sample to be
infection, in contrast, the titre of virus-specific IgG is higher at room temperature for approximately 30 minutes before
than IgM titre in whole of serological period.2,3) Although use.
there are many types of serological diagnostic reagents  The instrument for ichroma™ tests may generate slight
including enzyme-linked immunosorbent assay (ELISA) or vibration during use.
immunofluorescent assays (IFA), development of  Used cartridges, diluent tubes and pipette tips should be
simultaneous and accurate detection kit of IgG and IgM is handled carefully and discarded by an appropriate method
required.4) in accordance with relevant local regulations.
 The detector diluent contains sodium azide(NaN3), and it
PRINCIPLE may cause certain health issues like convulsions, low blood
The test uses a sandwich immunodetection method. pressure and heart rate, loss of consciousness, lung injury
The detector antigens in buffer bind to antibodies in the and respiratory failure. Avoid contact with skin, eyes, and
sample, forming antigen-antibody complexes, and migrate clothing. In case of contact, rinse immediately with
onto nitrocellulose matrix to be captured by the other running water.
immobilized-antibodies on a test strip.  ichroma™ Dengue IgG/IgM will provide accurate and
More antibodies in the sample will form more antigen- reliable results subject to the below conditions.
antibody complexes which lead to stronger fluorescence - ichroma™ Dengue IgG/IgM should be used only in
signal which is processed by the instrument for ichroma™ conjunction with the instrument for ichroma™ tests
tests to show the ‘dengue IgG/IgM positive’ in the sample. - Have to use recommended anticoagulant.
Recommended anticoagulant
COMPONENTS
EDTA, K2EDTA, K3EDTA,
ichroma™ Dengue IgG/IgM consists of ‘cartridges’, Sodium heparin, Lithium heparin, Sodium citrate
‘detector tubes’ and ‘detector diluent’.
 The cartridge contains the membrane called a test strip LIMITATION OF THE TEST SYSTEM
which has anti-human IgM, anti-human IgG at each test
 The test may yield false positive result(s) due to the cross-
lines respectively and chicken IgY at the control line. All
reactions and/or non-specific adhesion of certain sample
양식-GE02-15 (Rev. 04) 1 / 4
Document No. : INS-DG_E-EN
Revision date : May 19, 2022 (Rev. 02)

components to the capture/detector antibodies. month at 2 - 8 °C prior to being tested. If testing will be
 The test may yield false negative result(s) due to the non- delayed more than a month, it should be frozen at -20 °C.
responsiveness of the antigen to the antibodies which is  The sample (serum, plasma) stored frozen at -20 °C for 1
the most common if the epitope is masked by some year showed no performance difference.
unknown components, so therefore not being able to be  As a repeated freeze-thaw cycle may affect the test result,
detected or captured by the antibodies. The instability or do not refreeze previously frozen samples.
degradation of the antigen with time and/or temperature
may also cause false negative result as it makes the TEST SETUP
antigen unrecognizable by the antibodies.  Check the contents of ichroma™ Dengue IgG/IgM: Sealed
 Other factors may interfere with the test and cause cartridges, detector tubes, detector diluent, ID chip and an
erroneous results, such as technical/procedural errors, ‘instructions for use’.
degradation of the test components/reagents or presence  Ensure that the lot number of the cartridges matches that
of interfering substances in the test samples. of the diluent tube as well as an ID chip.
 Any clinical diagnosis based on the test result must be  If the sealed cartridge and the detection buffer have been
supported by a comprehensive judgment of the stored in a refrigerator, place them on a clean and flat
concerned physician in conjunction with clinical symptoms surface at room temperature for at least 30 minutes
and other relevant test results. before testing.
 Turn on the Instrument for ichroma™ tests.
STORAGE AND STABILITY
 Insert ID chip into the ‘ID chip port’.
Storage condition ※ Please refer to the ‘Instrument for ichroma™ tests
Storage Operation Manual’ for complete information and
Component Shelf life Note
Temperature operating instructions.
Cartridge 2 - 30 °C 20 months Disposable
Detector tube 2 - 30 °C 20 months Disposable TEST PROCEDURE
2 - 30 °C 20 months Unopened ▶ ichroma™ II, ichroma™ M2
Detector diluent
2 - 30 °C 20 months Opened Multi test mode / Read now mode
 After the cartridge pouch is opened, the test should be 1) Take 150 μL of detector diluent using a pipette and
performed immediately. dispense it to the detector tube containing a granule.
When the granule form is completely dissolved in the
MATERIALS SUPPLIED
tube, it becomes detection buffer.
REF CFPC-60 (The detection buffer must be used immediately. Do
Components of ichroma™ Dengue IgG/IgM not exceed 30 seconds.)
 Cartridge Box: 2) Take 5 µL of sample (whole blood/serum/plasma/
- Cartridge 25 control) using a pipette and dispense it to the detector
- Detector tube 25 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
- Instructions for use 1 (The sample mixture must be used immediately. Do not
exceed 30 seconds.)
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND 4) Take 75 µL of the sample mixture and dispense it into
Following items can be purchased separately from the sample well of the cartridge.
ichroma™ Dengue IgG/IgM. 5) Leave the cartridge at room temperature for 12
Please contact our sales division for more information. minutes.
 Instrument for ichroma™ tests Scan the sample-loaded cartridge immediately when
- ichroma™ II REF FPRR021 the incubation time is over. If not, it will cause
- ichroma™ III REF FPRR037 inaccurate test result.
- ichroma™ M2 REF FPRR031 6) To scan the sample-loaded cartridge, insert it into the
cartridge holder of the instrument for ichroma™ tests.
- ichroma™-50 PLUS REF FPRR036
Ensure proper orientation of the cartridge before
 Boditech Dengue IgG/IgM Control REF CFPO-280 pushing it all the way inside the cartridge holder. An
SAMPLE COLLECTION AND PROCESSING arrow is marked on the cartridge especially for this
purpose.
The sample type for ichroma™ Dengue IgG/IgM is human 7) Tap the ‘Start’ button on the instrument for ichroma™
whole blood/serum/plasma. tests to start the scanning process.
 It is recommended to test the sample within 24 hours after (ichroma™ M2 is tested automatically after inserting.)
collection. 8) The instrument for ichroma™ tests will start scanning
 The sample (serum, plasma) should be separated from the the sample-loaded cartridge immediately.
clot by centrifugation within 3 hours after the collection of 9) Read the test result on the display screen of the
whole blood. instrument for ichroma™ tests.
 The sample (serum, plasma) may be stored for up to a

양식-GE02-15 (Rev. 04) 2 / 4

Document No. : INS-DG_E-EN
Revision date : May 19, 2022 (Rev. 02)

Single test mode/ Walk away mode QUALITY CONTROL

1) The test procedure is same with the ‘Multi test mode 1)  Quality control tests are a part of the good testing practice
– 4)’. to confirm the expected results and validity of the assay
2) Insert the sample-loaded cartridge into the holder of and should be performed at regular intervals.
the instrument for ichroma™ tests. Ensure proper  Quality control tests should also be performed whenever
orientation of the cartridge before pushing it all the way there is any question concerning the validity of the test
inside the cartridge holder. An arrow is marked on the results.
cartridge especially for this purpose.  Control materials are provided on demand with ichroma™
3) Tap the ‘Start’ button on the instrument for ichroma™ Dengue IgG/IgM. For more information regarding
tests. obtaining the control materials, contact Boditech Med
(ichroma™ M2 is tested automatically after inserting.) Inc.’s Sales Division for assistance.
4) The cartridge goes inside the instrument for ichroma™ (Please refer to the instructions for use of control material.)
tests and will automatically start scanning the sample-
loaded cartridge after 12 minutes.
5) Read the test result on the display screen of the PERFORMANCE CHARACTERISTICS
instrument for ichroma™ tests.  Analytical Sensitivity
- Cut-off
▶ ichroma™ III The ichroma™ Dengue IgG/IgM test result indicates
1) The test procedure is same with the ‘Single test mode’. ‘positive’ or ‘negative’ of a sample defined by the
algorithm of ichroma™ reader based on COI (cut-off
▶ ichroma™-50 PLUS index).
1) Insert the tip array in the tip station. Cut-off index (COI) Result
2) Insert the detector tube in the reagent station and COI ≥ 1.1 Pos. for Dengue IgG / IgM
cover the reagent station to hold the detector tubes in 0.9 ≤ COI < 1.1 Indeterminate
place. COI < 0.9 Neg. for Dengue IgG / IgM
3) Open the lid of the detector diluent and insert the
detector diluent in the diluent station.  Analytical specificity
4) Insert the cartridge magazine with the cartridges into - Cross-reactivity
the magazine station. There was no false positive result from 8 species virus
5) Insert the sample tube into the blood collection tube samples containing potentially interfering substances
rack and load the blood collection tube rack into the with the ichroma™ Dengue IgG/IgM test.
sampling station (loading part). Cross-reactivity Materials
6) Tap the button located in the upper side of the No. of #1 Cytomegalovirus (CMV)
test cartridge region to select the ID chip that you want #2 Epstein-Barr virus (EBV)
to use. #3 Hepatitis A virus (HAV)
7) When the selected cartridge slot is activated, set the #4 Hepatitis C virus (HCV)
number of the detector tube by tapping. #5 Hepatitis B virus (HBV)
8) Set the number of pipette tips by tapping. #6 Anti-Nuclear antibody (ANA)
9) Tap the ‘Start’ button on the left upper of the main #7 Rheumatoid factor (RF)
screen to start test. #8 Zika
INTERPRETATION OF TEST RESULT - Interference
 The instrument for ichroma™ tests calculates the test Interferents listed in the following table were added to
result automatically and displays ‘G (COI value): P / N / I’ the test sample mentioned below. ichroma™ Dengue
,‘M (COI value): P / N / I’. IgG/IgM test results did not show any significant
 Ancillary value is served in the form of a cut-off index (COI). interference with these materials.
Cut-off Interferent Conc.
index Result Note Sodium Heparin 100,000 U/L
(COI) K2 EDTA 5 μM
Negative for No need to Sodium citrate 0.17 M
< 0.9 Bilirubin 500 μM
Dengue IgG/IgM additional test.
Hemoglobin 2 g/L
≥ 0.9, < 1.1 Indeterminate Need to retest.
Triglycerides 1.5 g/L
Positive for Need to Cholesterol 20 mM
≥ 1.1
Dengue IgG/IgM confirmation test. BSA 60 g/L
※ If test results are shown ‘Negative’ or ‘Indeterminate’
 Precision
repeatedly, these samples are considered dengue
- Between Lot
IgG/IgM antibody negative.
One person tested three different lots of ichroma™
Dengue IgG/IgM, ten times at each concentration of

양식-GE02-15 (Rev. 04) 3 / 4

Document No. : INS-DG_E-EN
Revision date : May 19, 2022 (Rev. 02)

the control standard. REFERENCES

- Between person
Three different persons tested same lot of ichroma™ 1. Evaluation of diagnostic test: Dengue. Rosanna W. P. et al.,
Dengue IgG/IgM, ten times at each concentration of Nature, 2010
the control standard. 2. Immunoglobulin G (IgG) to IgM ratio in secondary adult
- Between day dengue infection using samples from early days of
One person tested same lot of ichroma™ Dengue symptoms onset. Cucunawangsih et al., BMC Infectious
IgG/IgM for three days, ten times at each concentration Diseases, 2015
of the control standard. 3. Dengue Viraemia Titer, Antibody Response Pattern and
- Between site Virus Serotype Correlate with Disease Severity: Vaughn. D.
One person tested same lot of ichroma™ Dengue W. et. al., Journal of Infectious Diseases. 2000
IgG/IgM at three different sites, ten times at each 4. Current Global Status of Dengue Diagnostics: Miranda D.
concentration of the control standard. S. et. al., Journal of Advance in Biology and Biotechnology,
2015
Ig G
Note: Please refer to the table below to identify various
Between lot Between person
Standard material symbols.
Positive ratio Positive ratio
IgG(Neg.), IgM(Neg.) 0% 0%
IgG(Pos.), IgM(inde.) 100% 100%
IgG(Pos.), IgM(Pos.) 100% 100%
Between day Between site
Standard material
Positive ratio Positive ratio
IgG(Neg.), IgM(Neg.) 0% 0%
IgG(Pos.), IgM(inde.) 100% 100%
IgG(Pos.), IgM(Pos.) 100% 100%
Ig M
Between lot Between person
Standard material Positive ratio Positive ratio
IgG(Neg.), IgM(Neg.) 0% 0%
IgG(Pos.), IgM(inde.) 0% 0%
IgG(Pos.), IgM(Pos.) 100% 100%
Between day Between site
Standard material
Positive ratio Positive ratio
IgG(Neg.), IgM(Neg.) 0% 0%
IgG(Pos.), IgM(inde.) 0% 0%
IgG(Pos.), IgM(Pos.) 100% 100%
 Comparability
Comparator A (ELISA) For technical assistance, please contact:
Dengue IgG
Positive Negative Total Boditech Med Inc.’s Technical Services
ichroma™ Positive 60 0 60 Tel: +(82) -33-243-1400
Dengue Negative 1 21 22 E-mail: sales@[Link]
IgG/IgM Total 61 21 82
Comparator A (ELISA)
Dengue IgM Boditech Med Inc.
Positive Negative Total
Positive 18 1 19 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si,
ichroma™
Gang-won-do, 24398, Republic of Korea
Dengue Negative 2 32 34
Tel: +(82) -33-243-1400
IgG/IgM Total 20 33 53
Fax: +(82) -33-243-9373
- Percent positive agreement (PPA) of IgG = 98.4 %
[Link]
- Percent positive agreement (PPA) of IgM = 90 %
- Percent negative agreement (PNA) of IgG = 100 %
- Percent negative agreement (PNA) of IgM = 96.97 % Obelis s.a
Bd. Général Wahis 53, 1030 Brussels, Belgium
Tel: +(32) -2-732-59-54
Fax: +(32) -2-732-60-03
E-Mail: mail@[Link]

양식-GE02-15 (Rev. 04) 4 / 4