Please only refer to the current product lot insert enclosed with the kits package for execution

and reporting.

MAGLUMI Anti-HBc (CLIA)

INTENDED USE
The kit has been designed for the qualitative determination of
Hepatitis B core antibody (Anti-HBc) in human serum.
The test has to be performed on MAGLUMI Fully-auto
chemiluminescence immunoassay (CLIA) analyzer (Including
Fo
Shenzhen New Industries
Maglumi 600, Maglumi 800, Maglumi 1000, Maglumi 1000 Plus,
Biomedical Engineering Co., Ltd
Maglumi 2000, Maglumi 2000 Plus, Maglumi 4000).
No.16, Jinhui Road,
Catalog Number Specification
Pingshan New District,
130210005M 100 tests
Shenzhen, 518122, P.R.China.
130610005M 50 tests
Tel: +86-755-21536601
rR

Fax:+86-755-28292740
SUMMARY AND EXPLANATION OF THE TEST
HBV is transmitted through infected body fluids, including blood,
semen, and vaginal fluids (including menstrual blood). It also can
be transmitted from a pregnant woman to her child at or near the
FOR PROFESSIONAL USE ONLY
Store at 2-8°C time of delivery.
Hepatitis B surface antigen (HBsAg) is one of the most frequently
performed tests for HBV. This HBV antigen is the earliest indicator
ef

CAUTION: COMPLETELY READ THE of an active hepatitis B infection. This antigen may be present
INSTRUCTIONS BEFORE PROCEEDING
before symptoms of an HBV infection are present. If this antigen
level remains high for more than 6 months, then people will
probably become a carrier of HBV, meaning people can transmit it
to others throughout people’s life.
er

Hepatitis B surface antibody (HBsAb) is also one of the most

SYMBOLS EXPLANATIONS
common tests for HBV. Usually this antibody appears about 4
weeks after HBsAg disappears and means that the infection is at
MANUFACTURER
the end of its active stage and people cannot pass the virus to
en

others (people are no longer contagious). This antibody also

protects people from getting HBV again in the future. The test is
CONSULT INSTRUCTIONS FOR USE
done to determine the need for vaccination; the antibody will be
present after receiving the HBV vaccine series, showing that
people have protection (immunity) from the virus. Occasionally
KIT COMPONENTS
people’s test may show that people have both the HBsAb
ce

antibodies and HBsAg antigen; in this case, people are still

IN VITRO DIAGNOSTIC MEDICAL
contagious with hepatitis B core antigen (HBcAg). Currently, there
DEVICE
is no test to find this antigen. Hepatitis B core antibody (HBcAb) is
BATCH CODE an antibody to the hepatitis B core antigen. This antibody appears
about 1 month after an active HBV infection. It can be found in
people who had an infection in the past and in those with long-term
CATALOGUE NUMBER (chronic) HBV. It usually is present for life.
Hepatitis B e-antigen (HBeAg) is an HBV protein that is only
Us

USE BY present during an active HBV infection. This test determines how
contagious people are. Testing for this antigen can also be used to
monitor the effectiveness of treatment for HBV. Hepatitis B
TEMPERATURE LIMITATION
( STORE AT 2-8 °C) e-antibody (HBeAb) shows that the active stage of the HBV
infection is almost over and people’s risk of being contagious is
greatly reduced. HBeAb is usually present during chronic HBV
e

SUFFICIENT FOR infections.

PRINCIPLE OF THE TEST

KEEP AWAY FROM SUNLIGHT Competitive chemiluminescence immunoassay;
O

Use ABEI to label anti-HBc an monoclonal antibody, use FITC to

label purified HBc antigen, use an anti-FITC polyclonal antibody to
THIS WAY UP coat magnetic microbeads. Sample (or calibrator/control, if
applicable), ABEI Label, FITC Label and magnetic microbeads
nl

coated are mixed thoroughly and incubated at 37°C, forming

antibody-antigen complexes. After precipitation in a magnetic field,
decant the supernatant, and perform a wash cycle. Subsequently,
the starter 1+2 is added to initiate a flash chemiluminescent
reaction. The light signal is measured by a photomultiplier within 3
y

seconds as RLU which is proportional to the concentration of

Anti-HBc present in samples.

KIT COMPONENTS
Material Supplies
057 Anti-HBc-IFU-V3.06-en--others 1/4

This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

2) 2-Point Recalibration
Component 100 tests 50 tests
Via the measurement of calibrators, the predefined master curve is
Magnetic Microbeads: TRIS buffer,
adjusted (recalibrated) to a new, instrument-specific measurement
0.09%NaN3, coated with sheep 2.5 ml 2.0 ml level with each calibration.
anti-FITC polyclonal antibody.
Calibrator Low: phosphate buffer 3) Frequency of Recalibration
containing bovine serum and 2.5 ml 2.0 ml  After each exchange of lot (Reagent Integral or Starter

anti-HBc, 0.09% NaN3. Reagents).

Fo
Calibrator High: phosphate buffer  Every week and/or each time a new Integral is used
containing bovine serum and 2.5 ml 2.0 ml (recommended).
anti-HBc, 0.09% NaN3.  After each servicing of MAGLUMI Fully-auto
FITC Label: HBc recombinant antigen chemiluminescence immunoassay (CLIA) analyzer.
labeled with FITC, containing BSA, 6.5 ml 4.5 ml  If controls are beyond the expected range.

0.09%NaN3.  Whenever room temperature changes exceed 5 °C

ABEI Label: anti-HBc monoclonal
rR

(recommended).
antibody labeled with ABEI, 6.5 ml 4.5 ml
containing BSA, 0.09%NaN3. SPECIMEN COLLECTION AND PREPARATION
All reagents are provided ready-to-use. Sample material: serum
Collect 5.0ml venous blood into Blood Collection Tube. Separate
Reagent Vials in kit box serum by centrifugation after standing whole blood at room
Internal Quality Control: phosphate buffer temperature.
ef

containing bovine serum and anti-HBc, Avoid repeated freezing and thawing. The serum sample can be
2.0 ml
0.09% NaN3. (For target value, refer to frozen and thawed for only two times. Stored samples should be
Quality Control Information data sheet) thoroughly mixed prior to use (Vortex mixer).
Internal quality control is only applicable with MAGLUMI system. .Please ask local representative of SNIBE for more details if
For instructions for use and target value, refer to Quality Control people have any doubt.
er

Information data sheet. User needs to judge results with their own
standards and knowledge. Specimen Conditions
 Do not use specimens with the following conditions:

Accessories Required But Not Provided (a) heat-inactivated specimens;

(b) Cadaver specimens;
en

MAGLUMI Reaction Module REF: 630003

(c) Obvious microbial contamination.
MAGLUMI Starter 1+2 REF: 130299004M
 Use caution when handling patient specimens to prevent
MAGLUMI Wash Concentrate REF: 130299005M
cross contamination. Use of disposable pipettes or pipette tips
MAGLUMI Light Check REF: 130299006M
is recommended.
Please order accessories from Shenzhen New Industries  Inspect all samples for bubbles. Remove bubbles with an

Biomedical Engineering Co., Ltd (SNIBE) or our representative. applicator stick prior to analysis. Use a new applicator stick for
ce

each sample to prevent cross contamination.

 Serum specimens should be free of fibrin, red blood cells or

other particulate matter.

Preparation of the Reagent Integral
 Ensure that complete clot formation in serum specimens has
Before the sealing is removed, gentle and careful horizontal
taken place prior to centrifugation. Some specimens,
shaking of the Reagent Integral is essential (avoid foam formation!)
especially those from patients receiving anticoagulant or
Remove the sealing and turn the small wheel of the magnetic
thrombolytic therapy, may exhibit increased clotting time. If the
microbeads compartment to and fro, until the color of the
Us

specimen is centrifuged before a complete clotting, the

suspension has changed into brown. Place the Integral into the
presence of fibrin may cause erroneous results.
reagent area and let it stand there for 30 min. During this time, the
magnetic microbeads are automatically agitated and completely
Preparation for Analysis
resuspended.
 Patient specimens with a cloudy or turbid appearance must be
Do not interchange integral components from different
centrifuged prior to testing. Following centrifugation, avoid the
reagents or lots!
lipid layer (if present) when pipetting the specimen into a
e

sample cup or secondary tube.

Storage and Stability
 Specimens must be mixed thoroughly after thawing by low
 Sealed: Stored at 2-8° C until the expiration date.
speed vortexing or by gently inverting, and centrifuged prior to
 Opened: Stable for 4 weeks. To ensure the best kit
use to remove red blood cells or particulate matter to ensure
performance, it is recommended to place opened kits in the
O

consistency in the results. Multiple freeze-thaw cycles of

refrigerator if it’s not going to be used on-board during the next
specimens should be avoided.
12 hours.
 All samples (patient specimens or controls) should be tested

within 3 hours of being placed on board the MAGLUMI

nl

THIS WAY UP System. Refer to the SNIBE service for a more detailed
discussion of onboard sample storage constraints.

KEEP AWAY FROM SUNLIGHT Storage

 If testing will be delayed for more than 8 hours, remove serum
y

CALIBRATION AND TRACEABILITY from the serum separator, red blood cells or clot. Specimens
1) Traceability removed from the separator gel, cells or clot may be stored up
To perform an accurate calibration, we have provided the test to 12 hours at 2-8°C.
calibrators standardized against the WHO 1st International  Specimens can be stored up to 30 days frozen at -20° C or
Standard 95/522. colder.

057 Anti-HBc-IFU-V3.06-en--others 2/4

This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

15 min Incubation
Shipping 400 μl Wash cycle
 Before shipping specimens, it is recommended that 3s Measurement
specimens be removed from the serum separator, red blood
cells or clot. When shipped, specimens must be packaged
DILUTION
and labeled in compliance with applicable state, federal and
Samples with concentrations above the measuring range can be
international regulations covering the transport of clinical
diluted. After manual dilution, multiply the result by the dilution
specimens and infectious substances. Specimens must be
factor. After dilution by the analyzers, the analyzer software
Fo
shipped frozen (dry ice).
automatically takes the dilution into account when calculating the
WARNING AND PRECAUTIONS FOR USERS
sample concentration.
The automatic sample dilution is available after dilution settings
 For use in IN-VITRO diagnostic procedures only. are done in the MAGLUMI analyzer user software. Please follow
 Package insert instructions must be carefully followed. MALGUMI analyzer operating instructions.
Reliability of assay results cannot be guaranteed if there are
rR

any deviations from the instructions in this package insert. QUALITY CONTROL
 Observe quality control guidelines for medical laboratories.
Safety Precautions  Use suitable controls for in-house quality control. Controls
CAUTION: This product requires the handling of human should be run at least once every 24 hours (a run cannot
specimens. exceed 24 hours), once per reagent kit and after every
 All samples, biological reagents and materials used in the calibration. The control intervals should be adapted to each
assay must be considered potentially able to transmit laboratory’s individual requirements. Values obtained should
ef

infectious agents. They should therefore be disposed of in fall within the defined ranges. Each laboratory should
accordance with the prevailing regulations and guidelines of establish guidelines for corrective measures to be taken if
the agencies holding jurisdiction over the laboratory, and the values fall outside the range.
regulations of each country. Disposable materials must be
er

incinerated; liquid waste must be decontaminated with sodium LIMITATIONS OF THE PROCEDURE
hypochlorite at a final concentration of 5% for at least half an 1) Limitations
hour. Any materials to be reused must be autoclaved using an A skillful operation and strict adherence to the instructions are
overkill approach. A minimum of one hour at 121°C is usually necessary to obtain reliable results.
considered adequate, though the users must check the Procedural directions must be followed exactly and careful technique
en

effectiveness of their decontamination cycle by initially must be used to obtain valid results. Any modification of the
validating it and routinely using biological indicators. procedure is likely to alter the results.
 It is recommended that all human sourced materials be
Bacterial contamination or repeated freeze-thaw cycles may affect
considered potentially infectious and handled in accordance the test results.
with the 29 CFR. 1910.1030 Occupational exposure to
bloodborne pathogens. Biosafety Level 2 or other appropriate 2) Interfering Substances
ce

biosafety practices should be used for materials that contain

The assay is unaffected by bilirubin＜0.4 mg/ml, haemoglobin＜10
or are suspected of containing infectious agents.
 This product contains Sodium Azide; this material and its mg/ml or triglycerides＜20 mg/ml.
container must be disposed of in a safe way.
 Safety data sheets are available on request.
3) HAMA
Patient samples containing human anti-mouse antibodies (HAMA)
Handling Precautions
may give falsely elevated or decreased values. Although
Us

 Do not use reagent kits beyond the expiration date.

HAMA-neutralizing agents are added, extremely high HAMA
 Do not mix reagents from different reagent kits.
serum concentrations may occasionally influence results.
 Prior to loading the Reagent Kit on the system for the first time,

the microbeads requires mixing to re-suspend microbeads

RESULTS
that have settled during shipment.
1) Calculation of Results
 For microbeads mixing instructions, refer to the KIT
 The analyzer automatically calculates the Anti-HBc
COMPONENTS, Preparation of the Reagent Integral section
e

concentration in each sample by means of a calibration curve

of this package insert.
which is generated by a 2-point calibration master curve
 To avoid contamination, wear clean gloves when operating
procedure. The results are expressed in index/ml For further
with a reagent kit and sample.
information please refer to the operating instructions of
 Over time, residual liquids may dry on the kit surface, please
MAGLUMI Fully-auto chemiluminescence immunoassay
O

pay attention the silicon film still exists on the surface of the kit.
(CLIA) analyzer.
 For detailed discussion of handling precautions during system

operation, refer to the SNIBE service information.

2) Interpretation of Results
Results obtained with the MAGLUMI Anti-HBc assay can be
nl

TEST PROCEDURE
interpreted as follows:
To ensure proper test performance, strictly adhere to the operating
 Non-reactive: A result less than 100 index/ml (< 100 index/ml)
instructions of MAGLUMI Fully-auto chemiluminescence
is considered to be negative.
immunoassay (CLIA) analyzer. Each test parameter is identified
 Reactive: A result greater than or equal to 100 index/ml is
via a RFID tag on the Reagent Integral. For further information
y

(≥ 100 index/ml) considered to be positive.

please refer to the operating instructions of MAGLUMI Fully-auto
chemiluminescence immunoassay (CLIA) analyzer .
PERFORMANCE CHARACTERISTICS
40 μl Sample, calibrator
1) Precision
+40 μl ABEI label
Intra-assay coefficient of variation was evaluated on 3 different
+40 μl FITC label
levels of controls. Repeatedly measure 10 times in the same run to
+20 μl Magnetic microbeads
057 Anti-HBc-IFU-V3.06-en--others 3/4

This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.

calculate the coefficient of variation.

Intra-assay precision
Control Mean(index/ml) SD(index/ml) CV%
Level 1 39.77 1.49 3.75
Level 2 142.53 4.36 3.06
Level 3 392.02 12.04 3.07

Inter-assay coefficient of variation was evaluated on three batches

of kits. Repeatedly measured 3 different levels of controls 10 times
Fo

in the same run, and 30 times for each levels to calculate the
coefficient of variation.
Inter-assay precision
Control Mean(index/ml) SD(index/ml) CV%
Level 1 40.02 2.81 7.03
Level 2 145.32 9.50 6.54
Level 3 395.12 24.62 6.23
rR

2) Analytical Sensitivity
<6 index/ml.
The detection limit represents the lowest analyte level that can be
distinguished from zero.

3) Specificity
ef

The specificity of the Anti-HBc assay system was assessed by

measuring the apparent response of the assay to various
potentially cross reactive analytes.
No cross reaction with IgG or IgM antibody of HAV, HCV, HIV,
er

Syphilis, EBV. Non HBV infected sample which is RF or ANA

positive, this reagent’s determination results show negative.
When Anti-HBe=282.843 index/ml, the Anti-HBc detects results
show negative.
en

4) Recovery
Consider Calibrator High of known concentration as a sample,
dilute it by 1:2 ratio with diluents, and measure the diluted
concentration for 10 times. Then calculate the expected
concentration and recovery of measured concentration. The
recovery should be within 90% -110%.
ce

Expected Mean Measuring Recovery

171.914 index/ml 175.068 index/ml 101.8 %

REFERENCES
1. Maddrey WC. Hepatitis B: an important public health issue. J
Med Virol 2000;61:362-366.
2. Bozkaya H, Akatca US, Ayola B, et al. High degree of
Us

conservation in the hepatitis B virus core gene during the

immune tolerant phase in perinatally acquired chronic hepatitis
B virus infection. J Hepatol 1997;26:508-516.
3. Hannoun C, Horal P, Lindh M. Long-term mutation rates in the
hepatitis B virus genome. J Gen Virol 2000;81:75-83.
4. Habersetzer F, Zoulim F, Jusot JF, et al. Clinical evaluation of
e

the branched DNA assay for hepatitis B virus DNA detection in

patients with chronic hepatitis B lacking hepatitis B e-antigen
and treated with interferon-alpha. J Viral Hepat 1998;
6:407-414.
O

5. Lindh M, Horal P, Dhillon AP, et al. Hepatitis B virus DNA levels,

precore mutations, genotypes and histological activity in
chronic hepatitis B. J Viral Hepat 2000;7:258-267.
6. Maruyama T, Mitsui H, Maekawa H, et al. Emergence of the
precore mutant late in chronic hepatitis B infection correlates
nl

with the severity of liver injury and mutations in the core region.
Am J Gastroenterol 2000;95:2894-2904.
7. Knodell RG, Ishak KG, Black WC, et al. Formulation and
application of a numerical scoring system for assessing
y

histological activity in asymptomatic chronic active hepatitis.

Hepatology 1981;1:431-435.
8. Hannoun C, Horal P, Lindh M. Long-term mutation rates in the
hepatitis B virus genome. J Gen Virol 2000; 81:75-83.

057 Anti-HBc-IFU-V3.06-en--others 4/4

This document could not be used for the purpose of legal registration.