DiaSorin S.p.A.

Via Crescentino snc - 13040 Saluggia (VC) - Italy

www.diasorin.com
Tel. +39.0161.4871

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LIAISON ® XL Anti-HBs ([REF] 311220), LIAISON ® XL Anti-HBs Plus ([REF] 311230)

1. INTENDED USE
The LIAISON ® XL MUREX Anti-HBs assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative
determination of antibody to hepatitis B surface antigen (anti-HBs) in human serum or plasma samples.
Assay results in conjunction with other laboratory results and clinical information may be used as an aid in the determination
of the HBV immune status and in the diagnosis of hepatitis B virus (HBV) infection.
The test has to be performed on the LIAISON ® Analyzer family.

2. SUMMARY AND EXPLANATION OF THE TEST

Hepatitis is an inflammatory disease of the liver that can severely damage the organ. The disease can result from non-
infectious causes or from infectious viral and bacterial agents.
Viral hepatitis B is endemic throughout the world (2). The infection is spread primarily through percutaneous contact with
infected blood, e.g., sharing of needles by drug addicts or transfusion of blood products that have not been screened for
HBV (1, 18). The hepatitis B virus (HBV) is also found in virtually every type of human body fluid and has been known to be
spread through genital contact. HBV can be transmitted perinatally from mother to child (17).
The incubation period for hepatitis B averages 90 days (range: 40-180 days). Common symptoms include malaise, fever,
gastroenteritis and icterus. HBV infection can lead to (a) icteric hepatitis; (b) subclinical anicteric hepatitis; (c) fulminant
hepatitis; (d) chronic active or persistent hepatitis (7). Over 90% of adult patients with hepatitis B completely recover from
the acute illness, approximately 1% die of fulminant hepatitis, and approximately 6 to 10% become chronic active or
persistent carriers (10, 15).
Hepatitis B diagnosis has been based on the detection of serologic markers. Testing for these markers helps to determine
the presence of past or ongoing HBV infection, the acute or chronic stage of the disease, response to therapy, and/or the
immune status of the patient (4).
Before the onset of clinical illness, HBsAg is detectable in the serum, and its presence persists through the symptomatic
phase of illness. Following clinical illness, the titre of HBsAg begins to decline and eventually falls below a detectable level.
After HBsAg disappears, anti-HBs appears in the serum, although there is often a gap called the window period between the
disappearance of HBsAg and the appearance of anti-HBs (seroconversion). In approximately 10% of patients, HBsAg
persists indefinitely in serum and anti-HBs does not appear, indicating a chronic carrier state (9).
The presence of anti-HBs in serum indicates previous exposure to HBV and long-lasting acquired immunity (13). Low serum
titres of anti-HBs, however, can signal a lack of immunity to future HBV infection.
Detection of anti-HBs is therefore critical in establishing whether complete resolution of the infection has occurred as well as
in establishing the acquisition of immunity, whether acquired as a result of natural HBV infection or vaccination.
Vaccines based on either human plasma-derived or recombinant HBsAg are in widespread use (6, 14, 16) and have
emphasized the requirement for an accurate quantification of the immunoglobulin concentration (3, 5): measurement of anti-
HBs in vaccinees is essential to assessing the duration of protection after primary immunization and the need and timing of
booster doses (8, 11, 12). Anti-HBs testing is also crucial in identifying HBV-susceptible individuals in pre-vaccination
screening programmes.

3. PRINCIPLE OF THE PROCEDURE

The method for quantitative determination of anti-HBs is a direct, sandwich chemiluminescence immunoassay (CLIA).
Recombinant HBsAg (subtypes ad and ay) is used for coating magnetic particles (solid phase) and human HBsAg is linked
to an isoluminol derivative (isoluminol-HBsAg conjugate). During the incubation, anti-HBs present in calibrators, samples or
controls binds to the solid phase and HBsAg conjugate, thus forming a sandwich. After the incubation, the unbound material
is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and
hence the amount of isoluminol-HBsAg conjugate, is measured by a photomultiplier as relative light units (RLU) and is
indicative of anti-HBs concentration present in calibrators, samples or controls.

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4. MATERIALS PROVIDED

Reagent integral
Magnetic particles  [SORB] Magnetic particles coated with HBsAg obtained in mammalian cells by the recombinant DNA
(2.5 mL) technology (balanced ad and ay subtypes), BSA, PBS buffer, < 0.1% sodium azide.
Calibrator 1 [CAL|1] Human serum/plasma containing low levels of anti-HBs, fetal calf serum, EDTA, 0.2%
(2.3 mL) ProClin ® 300, preservatives. The calibrator concentrations (mIU/mL) are referenced to WHO
Second International Standard for anti-hepatitis B surface antigen (anti-HBs) immunoglobulin,
human (NIBSC code: 07/164, 2008).
Calibrator 2 [CAL|2] Human serum/plasma containing high levels of anti-HBs, fetal calf serum, EDTA, 0.2%
(2.3 mL) ProClin ® 300, preservatives, an inert blue dye. The calibrator concentrations (mIU/mL) are
referenced to WHO Second International Standard for anti-hepatitis B surface antigen
(anti-HBs) immunoglobulin, human (NIBSC code: 07/164, 2008).
Conjugate [CONJ] Heat -treated human HBsAg (balanced ad and ay subtypes), conjugated to an isoluminol
(20 mL) derivative, BSA, PBS buffer, EDTA, 0.2% ProClin ® 300, preservatives, an inert red dye.
Specimen diluent  [DIL|SPE] Human serum/plasma, EDTA, 0.2% ProClin ® 300, preservatives, an inert blue dye (only for
(28 mL) LIAISON ® XL MUREX Anti-HBs Plus, code 311230).
Number of tests 200
All reagents are supplied ready to use. The order of reagents reflects the layout of containers in the reagent integral.

Materials required but not provided (system related)

LIAISON ® XL Analyzer LIAISON ® Analyzer
LIAISON ® XL Cuvettes ([REF] X0016). LIAISON ® Module ([REF] 319130).
LIAISON ® XL Disposable Tips ([REF] X0015). –
LIAISON ® XL Starter Kit ([REF] 319200). LIAISON ® Starter Kit ([REF] 319102) or
LIAISON ® XL Starter Kit ([REF] 319200).
– LIAISON ® Light Check 12 ([REF] 319150).
LIAISON ® Wash/System Liquid ([REF] 319100). LIAISON ® Wash/System Liquid ([REF] 319100).
LIAISON ® XL Waste Bags ([REF] X0025). LIAISON ® Waste Bags ([REF] 450003).
– LIAISON ® Cleaning Kit ([REF] 310990).

Additionally required materials

LIAISON ® XL MUREX Anti-HBs controls (negative and positive) ([REF] 311221).

5. WARNINGS AND PRECAUTIONS

For in vitro diagnostic use.
All serum and plasma units used to produce the components provided in this kit have been tested for the presence of HBsAg,
anti-HCV, anti-HIV-1, anti-HIV-2 and found to be non-reactive, except for the conjugate, which is reactive for HBsAg.
The hepatitis B surface antigen has been heat treated (60°C for 10 hours) during the manufacturing process. Nevertheless,
complete inactivation should not be assumed. 
As, however, no test method can offer absolute assurance that pathogens are absent, all specimens of human origin should
be considered potentially infectious and handled with care.

6. SAFETY PRECAUTIONS
Do not eat, drink, smoke or apply cosmetics in the assay laboratory.
Do not pipette by mouth.
Avoid direct contact with potentially infected material by wearing laboratory clothing, protective goggles, and disposable
gloves. Wash hands thoroughly at the end of each assay.
Avoid splashing or forming an aerosol. All drops of biological reagent must be removed with a sodium hypochlorite solution
with 0.5% active chlorine, and the means used must be treated as infected waste.
All samples and reagents containing biological materials used for the assay must be considered as potentially able to
transmit infectious agents. The waste must be handled with care and disposed of in compliance with the laboratory
guidelines and the statutory provisions in force in each Country. Any materials for reuse must be appropriately sterilized in
compliance with the local laws and guidelines. Check the effectiveness of the sterilization/decontamination cycle.
Do not use kits or components beyond the expiration date given on the label.

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Pursuant to EC Regulation 1272/2008 (CLP) hazardous reagents are classified and labeled as follows:

REAGENTS: [CAL|1], [CAL|2], [CONJ], [DIL|SPE]

CLASSIFICATION: Skin sens. 1 H317
SIGNAL WORD: Warning
SYMBOLS / PICTOGRAMS:

GHS07 Exclamation mark

HAZARD STATEMENTS: H317 May cause an allergic skin reaction.
PRECAUTIONARY STATEMENTS: P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P363 Wash contaminated clothing before reuse.
CONTAINS:
(only substances prescribed pursuant to reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]
Article 18 of EC Regulation 1272/2008). and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1) (ProClin ® 300).

Pursuant to EC Regulation 1272/2008 (CLP), [SORB] is labeled as EUH210 safety data sheets available on request.
For additional information see Safety Data Sheets available on www.diasorin.com.

7. REAGENT PREPARATION

REAGENT INTEGRAL
Please note the following important reagent handling precautions:
Resuspension of magnetic particles
Magnetic particles must be completely resuspended before the integral is placed on the instrument. Follow the steps below
to ensure complete suspension:
Before the seal is removed, rotate the small wheel at the magnetic particle compartment until the colour of the suspension
has changed to brown. Gentle and careful side-to-side mixing may assist in the suspension of the magnetic particles
(avoid foam formation). Visually check the bottom of the magnetic particle vial to confirm that all settled magnetic particles
have been resuspended. Carefully wipe the surface of each septum to remove residual liquid.
Repeat as necessary until the magnetic particles are completely resuspended.
Foaming of reagents
In order to ensure optimal performance of the integral, foaming of reagents should be avoided. Adhere to the recommendation
below to prevent this occurrence:
Visually inspect the reagents, calibrators in particular (position two and three following the magnetic particle vial), to ensure
there is no foaming present before using the integral. If foam is present after resuspension of the magnetic particles, place
the integral on the instrument and allow the foam to dissipate. The integral is ready to use once the foam has dissipated and
the integral has remained onboard and mixing.
Loading of integral into the reagent area
LIAISON ® Analyzer
– Place the integral into the reagent area of the analyzer, with the bar code label facing left, and let it stand for 30 minutes
before using. The analyzer automatically stirs and completely resuspends the magnetic particles.
– Follow the analyzer operator’s manual to load the specimens and start the run.
LIAISON ® XL Analyzer
– LIAISON ® XL Analyzer is equipped with a built-in solid-state magnetic device which aids in the dispersal of microparticles
prior to placement of a reagent integral into the reagent area of the analyzer. Refer to the analyzer operator’s manual for
details.
a. Insert the reagent integral into the dedicated slot.
b. Allow the reagent integral to remain in the solid-state magnetic device for at least 30 seconds (up to several minutes).
Repeat as necessary.
– Place the integral into the reagent area of the analyzer, with the label facing left, and let it stand for 15 minutes before
using. The analyzer automatically stirs and completely resuspends the magnetic particles.
– Follow the analyzer operator’s manual to load the specimens and start the run.
CONTROLS
Refer to the LIAISON ® XL MUREX Anti-HBs Control Set instructions for use section for proper preparation and handling
instructions.

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8. REAGENT INTEGRAL STORAGE AND STABILITY
– Sealed: Stable at 2-8°C until the expiry date.
– Opened on board or at 2-8°C: Stability twelve weeks. 
Always use the same analyzer for a reagent integral already opened.
– Use the storage rack provided with the analyzer for upright storage of the reagent integral.
– Do not freeze.
– Keep upright for storage to facilitate later the proper resuspension of magnetic particles.
– Keep away from direct light.

9. SPECIMEN COLLECTION AND PREPARATION

Either human serum (from tubes with and without separator gel) or plasma may be used. The anticoagulants sodium citrate,
K 2 EDTA, sodium and lithium heparin, have been tested and may be used with this assay. The correct specimen type must
be used in the assay.
Follow the tube manufacturer’s instructions carefully when using collection containers. Blood should be collected aseptically
by venipuncture and the serum or plasma separated from clot, red cells or gel separator, after centrifugation.
Centrifugation conditions range from 1,000 to 3,000 g for 10 minutes. Conditions may vary depending on the tube
manufacturer’s recommendations. Use of alternate centrifugation conditions should be evaluated and validated by the
laboratory.
Before shipping specimens, serum or plasma specimens should be removed from clot, red cells or gel separator.
Specimens may be shipped in dry ice (frozen), in wet ice (for 2°-8°C) or at room temperature (20°-25°C), by following the
sample storage limitations described below.
Uncontrolled transport conditions (in terms of temperature and time) can cause inaccurate analytical results. During validation
studies, specimen collection tubes commercially available at the time of testing were used. Therefore, not all collection tubes
from all manufacturers have been evaluated. Blood collection devices from various manufacturers may contain substances
which could affect the test results in some cases (Bowen et al., Clinical Biochemistry, 43, 4-25, 2010).
Concerning storage limitations, if the assay is performed within seven days of the sample collection, the samples removed
from red cells, clot or gel separator may be kept at 2°-8°C; otherwise they should be aliquoted and stored deep-frozen (–20°C
or below). Six serum samples with different reactivity were stored for seven days at 2°-8°C and underwent six freeze-thaw
cycles. The results showed no significant differences; however multiple freeze-thaw cycles should be avoided. If the samples
are stored frozen, mix the thawed samples well before testing.
Six serum specimens were also stored at room temperature (20°-25°C) up to 72h and the results showed no significant
differences. However, room temperature storage conditions should be evaluated and validated by the laboratory.
Samples removed from red cells, clot or gel separator having particulate matter, fibrin, turbidity, lipaemia, or erythrocyte
debris, specimens that have been stored at room temperature (20°-25°C), or frozen and thawed, or samples requiring repeat
testing, require clarification by further centrifugation (it’s recommended 10,000 g for 10’) before testing, to improve the
consistency of results. Specimens with a lipid layer on the top should be transferred in a secondary tube, taking care to
transfer only the clarified material. Grossly haemolyzed or lipaemic samples, as well as samples containing particulate matter
or exhibiting obvious microbial contamination should not be tested. Check for and remove air bubbles before assaying.
The minimum volume required is 300 µL specimen (150 µL specimen + 150 µL dead volume).

10. CALIBRATION
Testing assay specific calibrators allows the detected relative light unit (RLU) values to adjust the assigned master curve.
Each calibration solution allows four calibrations to be performed.
Recalibration in triplicate is mandatory whenever at least one of the following conditions occurs:
– A new lot of Starter Kit is used.
– The previous calibration was performed more than eight weeks before.
– Each time a new lot of integral is used.
– The analyzer has been serviced.
– Control values lie outside the expected ranges.
LIAISON ® Analyzer: Calibrator values are stored in the bar codes on the integral label.
LIAISON ® XL Analyzer: Calibrator values are stored in the Radio Frequency IDentification transponder (RFID Tag).

11. ASSAY PROCEDURE

Strict adherence to the analyzer operator’s manual ensures proper assay performance.
LIAISON ® Analyzer. Each test parameter is identified via the bar codes on the reagent integral label. In the event that the
barcode label cannot be read by the analyzer, the integral cannot be used. Do not discard the reagent integral; contact your
local DiaSorin technical support for instruction.
LIAISON ® XL Analyzer. Each test parameter is identified via information encoded in the reagent integral Radio Frequency
IDentification transponder (RFID Tag). In the event that the RFID Tag cannot be read by the analyzer, the integral cannot
be used. Do not discard the reagent integral; contact your local DiaSorin technical support for instruction.
The analyzer operations are as follows:
1. Dispense calibrators, controls or specimens into the reaction module.
2. Dispense conjugate into the reaction module.
3. Dispense coated magnetic particles.
4. Incubate.
5. Wash with Wash/System liquid.
6. Add the Starter Kit and measure the light emitted.

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12. QUALITY CONTROL
LIAISON ® controls should be run in singlicate to monitor the assay performance. Quality control must be performed by
running LIAISON ® XL MUREX Anti-HBs controls
(a) at least once per day of use,
(b) whenever a new reagent integral is used,
(c) whenever the kit is calibrated,
(d) whenever a new lot of Starter Reagents is used.
Control values must lie within the expected ranges: whenever one or both controls lie outside the expected ranges, calibration
should be repeated and the controls retested. If the control values obtained after successful calibration lie repeatedly outside
the predefined ranges, the test should be repeated using an unopened control vial. If the control values lie outside the
expected ranges, the patient results must not be reported.
The performance of other controls should be evaluated for compatibility with this assay before they are used. Appropriate
value ranges should then be established for the quality control materials used.

13. INTERPRETATION OF RESULTS

The analyzer automatically calculates the anti-HBs concentrations expressed as mIU/mL and grades the results. For details,
refer to the analyzer operator’s manual.
Calibrators and controls may give different RLU or dose results on LIAISON ® and LIAISON ® XL, but the patient results are
equivalent.
The cut-off value discriminating between the presence and the absence of anti-HBs at levels consistent with immunity
against HBV infection is 10 mIU/mL. Sample results should be interpreted as follows:
Samples with anti-HBs concentrations below 9 mIU/mL should be graded negative.
Samples with anti-HBs concentrations ranging between 9 and 11 mIU/mL should be graded equivocal.
Equivocal samples should be retested in duplicate. Samples that are repeatedly above 10 mIU/mL (at least 2 out of 3 results)
should be considered positive. Samples that are repeatedly below 10 mIU/mL (at least 2 out of 3 results) should be
considered negative.
Samples with anti-HBs concentrations equal to or above 11 mIU/mL should be graded positive.

Assay range. 3 to 1000 mIU/mL anti-HBs (LIAISON ® XL MUREX Anti-HBs).

3 to 90,000 mIU/mL anti-HBs (LIAISON ® XL MUREX Anti-HBs Plus).
Samples containing antibody levels above the assay range may be prediluted by the Dilute function of the instrument and
retested (the recommended dilution factors are 1:50 and 1:90, only for LIAISON ® XL MUREX Anti-HBs Plus). The results will
then be automatically multiplied by the dilution factor to obtain the antibody levels of the neat specimens. The specimen diluent
available in the reagent integral allows up to 100 1:50 sample predilutions or 55 1:90 sample predilutions to be performed.

It is generally accepted that an anti-HBs concentration above 10 mIU/mL is indicative of either a resolution of a past
infection or a positive response to vaccination. In both cases, acquired immunity to type B viral hepatitis may be assumed.
Antibody concentrations below 10 mIU/mL are indicative of an absence of acquired immunity, as a level of 10 mIU/mL is
considered as the lower limit of protection.
Anti-HBs concentrations decrease over time after the basic course of immunization with hepatitis B vaccine. Several studies
have, however, shown that antibody concentrations remain protective even at undetectable levels for many years, at least
10 or 15, in immunocompetent vaccinees, who responded adequately to primary vaccination. It is in fact demonstrated that
long-term protection depends on immunologic memory.
This is the reason why most countries refrain from recommending a booster injection in immunocompetent individuals for at
least 15 years after neonatal vaccination, even though some countries do recommend a booster dose of vaccine. It is
therefore suggested to refer to the prevailing regulations and guidelines of each country for the frequency of antibody
concentration assay as well as the choice of injecting a booster vaccination.

14. LIMITATIONS OF THE PROCEDURE

• A skillful technique and strict adherence to the instructions are necessary to obtain reliable results. Bacterial contamination
or heat inactivation of the specimens may affect the test results.
• The use of citrate plasma specimens causes a decrease in the signal with the consequent underestimation of results
(of the order of 25%).
• Test results are reported quantitatively as positive or negative for the presence of anti-HBs. However, diagnosis of
infectious diseases should not be established on the basis of a single test result, but should be determined in conjunction
with clinical findings and other diagnostic procedures as well as in association with medical judgment.
• Comparison of quantitative results obtained with different assays on the same samples shows a certain degree of
concordance for the majority of samples. Individual samples, however, may give discrepant results. Various distinct
reasons are put forward (3):
– antigenic variability of HBsAg (presence and antibody binding characteristics of different HBsAg epitopes, antigen
purification procedures, HBsAg inactivation process, antigen conjugation or fixation to the solid phase)
– antibody composition of the analyte (specificity for different epitopes, different affinity for the same epitopes)
– assay specific features (e.g., correlation with the primary standard, assay principle, buffer system) or procedure for
calculation of results
– matrix effect in diluted and non-diluted samples and between samples and calibrators (e.g., presence of proteins, lipids).
• Integrals may not be exchanged between analyzer types (LIAISON ® and LIAISON ® XL). Once an integral has been
introduced to a particular analyzer type, it must always be used on that analyzer type until it has been exhausted.
• In order to maximize the reliability of results, follow-up of patients should not be performed on different analyzer types,
but instead the same analyzer type (either LIAISON ® or LIAISON ® XL) should be used.

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15. SPECIFIC PERFORMANCE CHARACTERISTICS

15.1. Analytical specificity

Analytical specificity may be defined as the ability of the assay to accurately detect specific analyte in the presence of
potentially interfering factors in the sample matrix (e.g., anticoagulants or cross-reactive antibodies).
Interference. Controlled studies of potentially interfering substances or conditions showed that the assay performance was
not affected by anticoagulants (sodium citrate, K 2 EDTA, lithium and sodium heparin) nor by the following compounds.
Tested Compound Tested concentration
Unconjugated bilirubin 20 mg/dL
Conjugated bilirubin 20 mg/dL
Hemoglobin 1000 mg/dL
Triglycerides 3000 mg/dL
Hypergammaglobulin (Immunoglobulin G) 60 g/L
Total protein (high) 120 g/L
Total protein (low) <60 g/L

Cross-reactions. The cross-reactivity study for the LIAISON ® XL MUREX Anti-HBs assay was designed to evaluate
potential interference from antibodies to other organisms that may cause clinical symptoms similar to those of HBV infection
(EBV, hCMV, rubella, measles and mumps viruses, HAV, HCV), from diseases that involve liver (liver cancer, fatty liver
disease), from antibodies to other organisms that may cause infectious diseases (HSV, VZV, HIV, Toxoplasma gondii,
Treponema pallidum, N. Gonorrhea, Parvovirus B19, Borrelia, HTLV I/II, Chlamydia trachomatis, Trypanosoma cruzi) as well
as from other conditions that may involve immune system activity (anti-nuclear autoantibodies, anti-Saccharomyces
cerevisiae antibodies, rheumatoid factor, human anti-mouse antibodies, autoimmune hepatitis, multiple myeloma,
monoclonal gammopathies, donors with flu vaccine, hemodialysis patients, multiple transfusion recipients). Samples for
these studies were pre-screened with other commercially available anti-HBs assays. If found negative for anti-HBs, those
specimens were used to study potential cross-reactivity. The presence of potential cross-reactants in the samples was
detected using CE-marked assays.
LIAISON ® XL
Number of expected
Condition negative samples MUREX Anti-HBs
positive results
hCMV antibodies 17 0
EBV (VCA) antibodies 9 0
HSV-1/2 antibodies 16 0
Rubella virus antibodies 22 0
Measles virus antibodies 6 0
Mumps virus antibodies 3 0
Parvovirus B19 antibodies 10 0
Borrelia antibodies 6 0
HTLV I/II antibodies 4 0
Chlamydia trachomatis antibodies 3 0
Trypanosoma cruzi antibodies 10 0
VZV antibodies 16 0
HCV antibodies 13 0
HIV I antibodies 8 0
HIV II antibodies 2 0
HAV antibodies 3 0
Toxoplasma gondii antibodies 10 0
Treponema pallidum antibodies 4 0
Rheumatoid factor (anti-Fc immunoglobulin) 7 0
Anti-nuclear autoantibodies (ANA) 5 0
Anti-Saccharomyces cerevisiae antibodies (ASCA) 2 0
Human anti-mouse antibodies (HAMA) 15 0
Hemodialysis patients 27 0
Autoimmune hepatitis 2 0
Fatty liver disease 4 0
Liver cancer 3 0
Monoclonal Gammopathy IgM 1 0
Monoclonal Gammopathy IgG 3 0
Donors with Flu vaccine 4 0
Multiple Myeloma 5 0
Multiple Transfusion Recipients 5 0
Neisseria gonorrhea antibodies 5 0
Total 250 0

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15.2. Precision with LIAISON ® Analyzer
Different samples, containing different concentrations of specific analyte, were assayed to estimate repeatability and
reproducibility of the assay (i.e., within- and between-assay variability). The variability shown in the tables below did not
result in sample misclassification. The results refer to the groups of samples investigated and are not guaranteed
specifications, as differences may exist between laboratories and locations.
Repeatability. Twenty replicates on 7 samples were performed in the same run to evaluate in-house repeatability.
Repeatability 1 2 3 4 5 6 7
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 33.6 13.0 73.7 111 169 517 6.79
Standard deviation (mIU/mL) 2.06 0.88 1.80 5.37 7.65 16.5 0.38
Coefficient of variation (%) 6.14 6.75 2.45 4.84 4.52 3.18 5.58
Min. value (mIU/mL) 29.0 11.3 70.9 101 156 483 6.10
Max. value (mIU/mL) 37.0 14.8 78.7 119 183 542 7.81

Reproducibility. Twenty replicates on 7 samples were performed in different days (one or two runs per day) with three
different lots of integral to evaluate reproducibility. The tests were performed in two sites, in house (site 1) and in an
independent laboratory (site 2), with one instrument per site.
Reproducibility - Site 1 A B C D E F G
LOT No. 01
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 57.8 6.36 9.63 94.1 229 363 627
Standard deviation (mIU/mL) 3.84 0.53 0.58 4.87 16.4 34.9 68.3
Coefficient of variation (%) 6.65 8.41 6.03 5.17 7.16 9.61 10.9
Min. value (mIU/mL) 49.7 5.31 8.24 86.7 189 282 457
Max. value (mIU/mL) 64.3 7.28 10.7 109 257 421 777
LOT No. 02
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 59.5 6.40 9.14 89.3 228 390 663
Standard deviation (mIU/mL) 4.53 0.41 0.72 6.15 8.96 24.8 40.5
Coefficient of variation (%) 7.61 6.38 7.90 6.88 3.94 6.36 6.12
Min. value (mIU/mL) 47.3 5.47 7.89 78.6 212 343 601
Max. value (mIU/mL) 66.3 7.04 10.5 102 242 427 743
LOT No. 03
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 56.4 6.77 10.1 95.4 242 361 637
Standard deviation (mIU/mL) 4.28 0.36 0.48 6.16 12.4 21.5 44.5
Coefficient of variation (%) 7.58 5.35 4.70 6.46 5.12 5.97 6.99
Min. value (mIU/mL) 50.2 6.03 9.47 86.3 217 324 586
Max. value (mIU/mL) 64.2 7.00 11.5 112 266 401 731
Inter-lot coefficient of variation (%) 7.50 7.23 7.42 6.71 6.17 8.15 8.39

Reproducibility - Site 2 A B C D E F G
LOT No. 01
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 53.3 6.49 9.52 92.0 234 360 616
Standard deviation (mIU/mL) 7.10 0.45 1.10 9.33 23.8 39.9 63.7
Coefficient of variation (%) 13.3 6.90 11.5 10.1 10.2 11.1 10.3
Min. value (mIU/mL) 41.2 5.68 7.40 71.5 179 272 461
Max. value (mIU/mL) 63.7 7.17 10.6 101 272 406 713
LOT No. 02
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 60.6 6.95 10.0 92.6 232 395 608
Standard deviation (mIU/mL) 6.72 0.67 1.41 11.6 26.8 57.1 85.3
Coefficient of variation (%) 11.1 9.69 14.1 12.5 11.5 14.5 14.0
Min. value (mIU/mL) 46.8 5.77 7.78 72.1 187 301 444
Max. value (mIU/mL) 70.1 8.47 11.9 108 271 458 736
LOT No. 03
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 57.4 6.66 9.51 90.5 226 340 579
Standard deviation (mIU/mL) 6.64 0.73 1.19 9.96 25.6 48.8 83.1
Coefficient of variation (%) 11.6 10.9 12.5 11.0 11.3 14.4 14.3
Min. value (mIU/mL) 41.3 5.46 7.39 73.5 174 250 433
Max. value (mIU/mL) 66.3 8.02 11.2 106 258 411 676
Inter-lot coefficient of variation (%) 12.9 9.65 12.8 11.1 10.9 14.6 13.0

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15.3. Precision with LIAISON ® XL Analyzer
Different samples, containing different concentrations of specific analyte, were assayed to estimate repeatability and
reproducibility of the assay (i.e., within- and between-assay variability). The variability shown in the tables below did not
result in sample misclassification. The results refer to the groups of samples investigated and are not guaranteed
specifications, as differences may exist between laboratories and locations.
Repeatability. Twenty replicates on 7 samples were performed in the same run to evaluate repeatability.
Repeatability A B C D E F G
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 56.5 11.0 94.6 246 392 663 7.11
Standard deviation (mIU/mL) 1.66 0.31 3.19 5.84 9.82 30.7 0.29
Coefficient of variation (%) 2.95 2.80 3.37 2.38 2.51 4.63 4.06
Min. value (mIU/mL) 53.5 10.4 89.0 237 372 601 6.62
Max. value (mIU/mL) 59.7 11.5 99.9 257 408 714 7.82

Reproducibility. Twenty replicates on 7 samples were performed in different days (one or two runs per day) with three
different lots of integral to evaluate reproducibility. The tests were performed in two sites, in house (site 1) and in an
independent laboratory (site 2), with one instrument per site.
Reproducibility - Site 1 A B C D E F G
LOT No. 01
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 58.2 6.47 10.2 95.9 257 419 701
Standard deviation (mIU/mL) 1.33 0.17 0.20 2.34 5.69 11.3 37.3
Coefficient of variation (%) 2.29 2.65 1.93 2.44 2.21 2.69 5.31
Min. value (mIU/mL) 55.2 6.21 9.71 91.3 246 401 634
Max. value (mIU/mL) 60.7 6.77 10.6 98.9 269 442 775
LOT No. 02
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 49.0 5.22 8.02 75.7 210 355 545
Standard deviation (mIU/mL) 2.86 0.31 0.65 3.45 7.89 17.2 31.9
Coefficient of variation (%) 5.85 5.84 8.11 4.55 3.76 4.83 5.85
Min. value (mIU/mL) 42.7 4.62 6.78 67.5 193 317 479
Max. value (mIU/mL) 52.4 5.74 8.93 79.1 218 386 586
LOT No. 03
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 54.4 6.67 10.3 90.7 243 386 639
Standard deviation (mIU/mL) 1.22 0.35 0.26 2.30 4.76 9.29 24.6
Coefficient of variation (%) 2.25 5.23 2.57 2.54 1.96 2.41 3.85
Min. value (mIU/mL) 52.5 6.19 9.79 86.8 234 372 590
Max. value (mIU/mL) 56.8 7.82 10.9 96.9 251 402 683
Inter-lot coefficient of variation (%) 7.92 11.5 12.0 10.3 8.93 7.50 11.5

Reproducibility - Site 2 A B C D E F G
LOT No. 01
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 57.7 6.62 10.6 94.0 251 410 657
Standard deviation (mIU/mL) 2.72 0.44 0.31 3.44 11.6 12.5 41.0
Coefficient of variation (%) 4.72 6.62 2.95 3.66 4.63 3.05 6.24
Min. value (mIU/mL) 53.8 5.11 10.1 87.6 220 392 516
Max. value (mIU/mL) 66.6 7.15 11.0 101 270 445 714
LOT No. 02
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 53.0 5.58 9.00 80.8 219 372 563
Standard deviation (mIU/mL) 2.29 0.22 0.28 2.95 9.89 15.0 42.6
Coefficient of variation (%) 4.32 3.99 3.15 3.65 4.52 4.02 7.57
Min. value (mIU/mL) 49.3 5.15 8.45 74.0 196 351 445
Max. value (mIU/mL) 58.3 5.93 9.69 86.0 237 402 626
LOT No. 03
Number of determinations 20 20 20 20 20 20 20
Mean (mIU/mL) 55.6 6.84 10.6 90.4 241 376 624
Standard deviation (mIU/mL) 2.39 0.25 0.27 4.05 7.82 11.3 49.7
Coefficient of variation (%) 4.29 3.67 2.55 4.48 3.24 3.01 7.96
Min. value (mIU/mL) 50.5 6.16 9.99 81.7 228 351 468
Max. value (mIU/mL) 59.4 7.26 11.1 97.9 253 395 695
Inter-lot coefficient of variation (%) 5.60 10.0 8.05 7.45 7.01 5.60 9.59

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15.4. Trueness
The assay trueness has been checked by the dilution test.
Dilution test. Ten serum samples containing high anti-HBs concentrations were tested as such and after serial dilution with
specimen diluent. The anti HBs results were analyzed as a linear regression of the Observed vs. Expected values.
The resulting slopes ranged from 0.90 to 1.02, while correlation coefficients (r) ranged from 0.979 to 1.000, when using the
LIAISON ® instrument, and the resulting slopes ranged from 0.99 to 1.01, while correlation coefficients (r) ranged from 0.995
to 1.000, when using the LIAISON ® XL Analyzer.
15.5. High-dose hook effect
Whenever samples containing extremely high antibody concentrations are tested in a sandwich method, the hook effect can
mimic concentrations lower than the real one. For correct quantification, samples containing levels greater than that of the
assay range should be diluted with a negative sample or the LIAISON ® XL MUREX Anti-HBs Plus specimen diluent and
retested. The results must then be multiplied by the dilution factor to obtain the levels of the neat specimens.
The kit has been designed in such a way that doses up to 570,000 mIU/mL anti-HBs produce an analytical signal which is
still above the assay range.
Analysis of the hook effect was evaluated by testing three high-titred samples positive for anti-HBs. All samples resulted in
concentration values above the assay range that would be expected with high-titred sera, indicating no sample
misclassification.
15.6. Analytical and functional sensitivity
The Limit of Blank (LoB) is 0.74 mIU/mL, determined as 95 th Percentile of a population of 60 negative samples.
Following the method from CLSI EP17-A, the Limit of Detection (LoD) and the Limit of Quantitation (LoQ) for the
LIAISON ® XL MUREX Anti-HBs assay, are both fixed at 3 mIU/mL after assessment.
LoQ is defined as the concentration at which the between-assay coefficient of variation (CV) exceeds 20%.
15.7. Diagnostic specificity and sensitivity
Selected populations. Diagnostic specificity and sensitivity were assessed by testing 600 specimens collected from
different selected populations (subjects never infected by HBV, subjects with past natural HBV infection, HBV vaccinees).
The specimens were tested by the reference method. Available clinical and additional serological data were applied to
discrepancies to define the expected results.
No positive and 214 negative results were observed in the expected negative population studied (subjects serologically
defined as never infected by HBV) - diagnostic specificity: 100% (95% confidence interval: 98.3-100%).
No negative and 134 positive results were observed in the expected positive population studied (subjects serologically
defined as past natural HBV infection) - diagnostic sensitivity: 100% (95% confidence interval: 97.3-100%).
No negative and 252 positive results were observed in the expected positive population of HBV vaccinees (subjects
serologically defined as HBc negative marker) - diagnostic sensitivity: 100% (95% confidence interval: 98.5-100%).
In addition, diagnostic sensitivity was evaluated on 15 panels, follow-up of vaccination, encompassing 64 bleeds, each
starting with a negative bleed and exhibiting narrow bleeding intervals. The test shows a substantial equivalence in the
timing of detection with respect to the reference methods.
Prospective population. Diagnostic specificity and sensitivity were assessed by testing 737 specimens collected from
subjects sent to the lab for anti-HBs testing. The specimens were tested in parallel with a reference CE-marked method.
Consensus with additional serological data was applied to define the expected results.
2 positive and 442 negative results were observed in the expected negative population studied - diagnostic specificity: 99.5%
(95% confidence interval: 98.4-99.9%).
2 negative and 286 positive results were observed after repeat testing of discrepant samples in the expected positive
population studied - diagnostic sensitivity: 99.3% (95% confidence interval: 97.5-99.9%).

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Changes: §14;
Deletions: -

LIAISON ® XL Control Anti-HBs ([REF] 311221)

1. INTENDED USE
The LIAISON ® XL MUREX Anti-HBs controls (negative and positive) are to be used in LIAISON ® chemiluminescence
immunoassays (CLIA) as a means of checking the reliability of assay runs. The performance characteristics of LIAISON ® XL
MUREX Anti-HBs controls have not been established in connection with any other assays or instrument platforms different
from LIAISON ® and LIAISON ® XL.
LIAISON ® Analyzer. The certificate of analysis gives specific information on the lot of controls, which should be manually
entered in the analyzer software prior to loading the control vials on board. For details, refer to the analyzer operator’s
manual.
LIAISON ® XL Analyzer. The certificate of analysis bar codes give specific information on the lot of controls and should be
read by the hand-held bar code scanner of the LIAISON ® XL Analyzer prior to loading the control vials on board. For details,
refer to the analyzer operator’s manual.

2. MATERIALS PROVIDED
Negative control [CONTROL|-] Human serum/plasma without anti-HBs antibodies, with TRIS buffer, 0.2% ProClin ® 300
(2 x 2.5 mL) and preservatives.
Positive control [CONTROL|+] Human serum/plasma containing anti-HBs antibodies (human), fetal calf serum, EDTA,
(2 x 2.5 mL) 0.2% ProClin ® 300 and preservatives.
All reagents are supplied ready to use. The range of concentrations of each control is reported on the certificate of analysis
and indicates the limits established by DiaSorin for control values that can be obtained in reliable assay runs.
Each laboratory is responsible for adopting different limits to meet individual requirements.

3.WARNINGS AND PRECAUTIONS

– For in vitro diagnostic use.
– Controls are not kit lot specific and may be safely interchanged even with different reagent integral lots.
– All materials used to produce the components provided in this kit have been tested for the presence of HBsAg, anti-HCV,
anti-HIV-1, anti-HIV-2 and found to be non-reactive. As, however, no test method can offer absolute assurance that
pathogens are absent, all specimens of human origin should be considered potentially infectious and handled with care.
Observe the normal precautions required for handling all laboratory reagents.
– Disposal of all waste material should be in accordance with local guidelines.

4. SAFETY PRECAUTIONS
Do not eat, drink, smoke or apply cosmetics in the assay laboratory.
Do not pipette by mouth.
Avoid direct contact with potentially infected material by wearing laboratory clothing, protective goggles, and disposable
gloves. Wash hands thoroughly at the end of each assay.
Avoid splashing or forming an aerosol. All drops of biological reagent must be removed with a sodium hypochlorite solution
with 0.5% active chlorine, and the means used must be treated as infected waste.
All samples and reagents containing biological materials used for the assay must be considered as potentially able to
transmit infectious agents. The waste must be handled with care and disposed of in compliance with the laboratory
guidelines and the statutory provisions in force in each Country. Any materials for reuse must be appropriately sterilized in
compliance with the local laws and guidelines. Check the effectiveness of the sterilization/decontamination cycle.
Do not use kits or components beyond the expiration date given on the label.
Pursuant to EC Regulation 1272/2008 (CLP) hazardous reagents are classified and labeled as follows:
REAGENTS: [CONTROL|-], [CONTROL|+]
CLASSIFICATION: Skin sens. 1 H317
SIGNAL WORD: Warning
SYMBOLS / PICTOGRAMS:

GHS07 Exclamation mark

HAZARD STATEMENTS: H317 May cause an allergic skin reaction.
PRECAUTIONARY STATEMENTS: P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P363 Wash contaminated clothing before reuse.
CONTAINS:
(only substances prescribed pursuant to reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and
Article 18 of EC Regulation 1272/2008). 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1). (ProClin® 300).

For additional information see Safety Data Sheets available on www.diasorin.com

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5. STORAGE AND STABILITY
Upon receipt, the controls must be stored at 2-8°C in an upright position to prevent adherence of the solution to the vial cap.
Do not freeze. When controls are stored, sealed and kept upright, they are stable at 2-8°C up to the expiry date. Once opened
controls are stable for twelve weeks when properly stored at 2-8°C between two successive uses. Avoid bacterial
contamination of controls. The controls should not be used past the expiry date indicated on the vial labels.

6.PREPARATION OF REAGENTS
– Place the control vials in type C racks on the analyzer. Each control vial allows at least 13 tests to be performed.
– The minimum volume required is 550 μL (150 μL control + 400 μL dead volume).
– At the time of use, equilibrate controls to room temperature (20-25°C) before opening the vials and keep them on board
the instrument only for the amount of time required for quality control testing.
– After use, close the vials promptly and store them at 2-8°C in an upright position.
– During handling, use appropriate precautions to avoid bacterial contamination of controls.

7. HANDLING
For proper handling please refer to the analyzer operator’s manual.

8. TARGET VALUES
The target values and ranges of anti-HBs concentrations in the controls are printed on the certificate of analysis. They have
been established after taking into account run variability with respect to the stored master curve, in order to guarantee the
accuracy of analytical results and to obtain indications on the stability or deterioration of reagents. If controls values lie
repeatedly outside the expected ranges, the test has most probably been performed incorrectly.

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REFERENCES

1. R.D. AACH et al.

Risk of transfusing blood containing antibody to hepatitis B surface antigen.
Lancet, 7874 : 190-193 (1974).
2. L.F. BARKER, R.J. DODD, S.G. SANDLER
Epidemiology of hepatitis B and post-transfusion and nosocomial hepatitis.
In: Viral Hepatitis: Laboratory and Clinical Science, F. Deinhardt, J. Deinhardt eds., M. Dekker Inc., New York, p. 215-230 (1983).
3. H. BORNHAK, W. JILG, H. HÜDIG, J. KAUFMANN
Quantitation of anti-HBs in solid phase immunoassays. What influences the results?
Poster presented at the International Symposium on Viral Hepatitis and Liver Disease, Tokyo, May 10-14, 1993.
4. M.R. BRUNETTO, F. OLIVERI, F. BONINO
Hepatitis B virus infection.
In: Progress in Hepatitis Research, O. Crivelli ed., DiaSorin Monograph, p. 9-30 (1991).
5. P. CROVARI, E. GASPARINI, G.C. ICARDI, R. COPPOLA
Quantitative evaluation of anti-HBs in sera.
Boll. Ist. Sieroter. Milan., 63 (1) : 14-18 (1984).
6. M. DAVIDSON, S. KRUGMAN
Recombinant yeast hepatitis B vaccine compared with plasma derived vaccine. Immunogenicity and effect of a booster dose.
J. Inf., 13 : 31-38 (1986).
7. F. GYORKEY et al.
Experimental carcinoma in macaque monkeys exposed to diethylnitrosamine and hepatitis B virus.
J. Natl. Cancer Inst., 59 (5) : 1451-1467 (1977).
8. S. HADLER et al.
Long-term immunogenicity and efficacity of hepatitis B vaccine in homosexual men.
N.E.J. Med., 315 (4) : 209-214 (1986).
9. J.H. HOOFNAGLE, D.A. SHAFRITZ, H. POPPER
Chronic type B hepatitis and the "healthy" HBsAg carrier state.
Hepatology, 7 : 758-763 (1987).
10. C.L. HOWARD
The biology of hepadnaviruses.
J. Gen. Virol., 67 : 1215-1235 (1986).
11. W. JILG., M. SCHMIDT, F. DEINHARDT
Persistence of specific antibodies after hepatitis B vaccination.
J. Hepatol., 6 : 201-207 (1988).
12. W. JILG, M. SCHMIDT, F. DEINHARDT
Hepatitis B vaccination: strategy for booster doses in high risk population groups.
In: Progress in Hepatitis B Immunization, P. Coursaget, M.J. Tong eds., Colloque INSERM, vol. 194, p. 419-427 (1990).
13. P. MICHEL et al.
Éradication de l’hépatite B chez les dialysés chroniques par séro-vaccinations répétées.
Néphrologie, 7 (3) : 114-117 (1986).
14. W. SZMUNESS et al.
Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States.
N.E.J. Med., 303 (15) : 833-836 (1980).
15. P. TIOLLAIS, C. POURCEL, A. DEJAN
The hepatitis B virus.
Nature, 317 : 489-495 (1985).
16. A.R. ZANETTI, E. TANZI, L. ROMANÒ, M. COCCHIONI
The control of hepatitis B by vaccination.
In: Progress in Hepatitis Research, O. Crivelli ed., DiaSorin Monograph, p. 79-91 (1991).
17. A.J. ZUCKERMANN
Post-transfusion hepatitis.
In: Human Virus Hepatitis, Elsevier/North Holland Biomedical Press, New York (2nd edition), p. 207-224 (1975).
18. A.J. ZUCKERMANN, C.R. HOWARD
In: Hepatitis Viruses of Man, Academic Press, London (1979).

Additional References

Viral Hepatitis and Liver Disease.

Proceedings of IX Triennial International Symposium on Viral Hepatitis and Liver Disease, Rome, Italy, 21-25 April 1996, M. Rizzetto, R.H. Purcell, J.L.
Gerin, G. Verme eds., Edizioni Minerva Medica, Turin, Italy (1997).
S. KINN, S. AKHAVAN, H. AGUT, V. THIBAULT
Performance of the DiaSorin LIAISON ® anti-HBs II for the detection of hepatitis B surface antibodies: comparison with the Abbott Architect anti-HBs
assay.
J. Clin. Virol., 50 : 297-302 (2011).
D. HUZLY, T. SCHENK, W. JILG, D. NEUMANN-HAEFELIN
Comparison of nine commercially available assays for quantification of antibody response to hepatitis B virus surface antigen.
J. Clin. Microbiol., 46 (4) : 1298-1306 (2008).

200/007-063, 04 - 2019-04

Anti-HBs XL-rf.fm LIAISON® XL MUREX Anti-HBs ([REF] 311220), LIAISON® XL MUREX Anti-HBs Plus ([REF] 311230)
1/1 200/007-063, 04 - 2019-04