VIDAS® Anti-HCV - ILEX Medical Systems

VIDAS® Anti-HCV - ILEX Medical Systems
‫‪ 17‬אפריל‪2012 ,‬‬
‫לקוחות נכבדים‪,‬‬
‫הנדון‪ :‬השקת קיט חדש ‪ -Vidas Anti HCV‬מחברת ‪bioMerieux‬‬
‫חברת אילקס שמחה להודיע על השקת ערכה חדשה בפאנל בדיקות הצהבת במכשיר ה‪Vidas -‬‬
‫בדיקת ‪ Anti HCV‬לבדיקת נוגדנים כנגד ‪.Hepatatis C Virus‬‬
‫‪rd‬‬
‫הקיט‪ , 3 Generation ,‬מגלה נוגדנים כנגד ‪ 3‬סוגים שונים של ‪ HCV Ag‬בדגימה‪:‬‬
‫• ‪Nucleocapsid CORE‬‬
‫• ‪NS3‬‬
‫• ‪NS4‬‬
‫עם ההשקה אנו גאים להציג פאנל שלם לבדיקות הצהבת‪:‬‬
‫• הפטטיס ‪IgG & IgM : A‬‬
‫• הפטטיס ‪HBsAg, HBc IgM&IgG, HBe/Anti HBe, Anti HBs : B‬‬
‫• הפטטיס ‪Anti HCV : C‬‬
‫יתרונות הערכה‪:‬‬
‫‪ .1‬הרצת קליברטור בדופליקט פעם ב‪ 28-‬יום‪.‬‬
‫‪ .2‬נפח דגימה ‪100 ul‬‬
‫‪ .3‬ריאגנטים בקיט ‪S1/C1 Ready To Use :‬‬
‫‪ .4‬הקיט ניתן לשימוש מיד עם הוצאתו מהמקרר‬
‫‪ .5‬אינטרפרטציה של תוצאות‪:‬‬
‫‪<1 → Negative‬‬
‫‪≥1 → Positive‬‬
‫להלן המק"ט להזמנה‪:‬‬
‫שם פריט‬
‫‪VIDAS ANTI HCV 60 TESTS‬‬
‫מק"ט אילקס‬
‫‪5-30308‬‬
‫מצ"ב מידע מחברת ‪.bioMerieux‬‬
‫נשמח לסייע במידע נוסף שיידרש‪.‬‬
‫בברכה‪,‬‬
‫אורלי דויטש‪054-5686303 ,‬‬
‫עילית ליזרמן‪054-6686183 ,‬‬
H E P A T I T I S
®
VIDAS ,
Designed to last
* Ease-of-use: Load and Go
* Robustness: MTBF > 700 days
03-12 / 9303110/008/GB/A / This document is not legally binding. bioMérieux reserves the right to modify specifications without notice. BIOMERIEUX, the blue logo and VIDAS are used, pending and/or registered trademarks
belonging to bioMérieux S.A. or one of its subsidiaries / bioMérieux SA RCS Lyon 673 602 399 / Photos: Getty Images, GraphicObsession, Fotolia, Norbertj / Printed in France / THERA Conseil / RCS Lyon B 398 160 242.
* High Quality tests for reliable diagnosis
®
VIDAS ,
a Customized Solution
for your Daily Workload
* Routine Testing
s5PTOPARAMETERSINONERUN
s#OMPREHENSIVEPANELS4HYROID&ERTILITY#ARDIAC-ARKERS
Tumor Markers, HIV, Hepatitis, ToRC…)
* Cost effective solution:
- Single dose
- All inclusive kits
- Convenient packaging size
C
* Complementary and Specialized Testing
s#ONlRMATORYTESTING()6$5/4OXO!VIDITY
DD Exclusion, Prolactin…)
s3PECIALIZEDTESTING,YME-EASLES-UMPS
H. pylori, CD A/B, Chlamydia, Allergy…)
s#OMPLEMENTARY4ESTINGLARGEMENUPARAMETERS
VIDAS and mini VIDAS
The adapted offer to your organization
* Emergency Testing
sAVAILABLE
s2APIDRESULTSINCOMPLIANCEWITH
Healthcare guidelines
s%MERGENCYPANEL4.)5#+-"
Myoglobin, NT-proBNP, DD Exclusion,
PCT, Digoxin, hCG…
VIDAS ® ANTI-HCV
For Clear and Confident
Diagnosis of Hepatitis C
bioMérieux S.A.
69280 Marcy l’Etoile
France
Tel. : +33 (0)4 78 87 20 00
Fax : +33 (0)4 78 87 20 90
www.biomerieux.com
www.biomerieux-diagnostics.com
The A, B, C ‘s of Hepatitis Testing
Viral hepatitis is a major global healthcare problem, responsible for significant morbidity
and socio-economic losses, with an estimated 3% of the world’s population infected
with HCV alone. The VIDAS hepatitis panel now covers all the must have parameters
for differential diagnosis of HAV, HBV and HCV, so you can provide:
* Adjusted treatment
* Better patient management
Hepatitis A
Hepatitis B
Total anti-HBc Ab
Total anti-HAV Ab
HBs Ag
Anti-HBe
4-12
weeks
2-7 weeks
Anti-HBe
Anti-HBc
IgM IgM
Anti-HAV
Anti-HBc IgM
VIDAS anti-HCV to support you
in Hepatitis C investigations
Anti-HCV Ab
HCV Ag
HCV RNA
HBe Ag
Acute
phase
Acute
phase
2-12 weeks
several days-2
weeks
Convalescence
Cure
Cure
2-16
weeks
3-8 months
years
years
* Diagnosis of recent infection:
VIDAS HAV IgM
Acute phase
Convalescence
Cure
4-12 weeks
2-12 weeks
2-16 weeks
years
VIDAS HBs Ag Ultra
s5LTRASENSITIVITYTO
- Reduce the serological windows
- Highlight hidden infections
- Detect HBV variant/mutant
®
VIDAS Anti-HAV Total
VIDAS HEPATITIS PANEL
* THE FLEXIBILITY YOU NEED
VIDAS HBc IgM II
s3ENSITIVEANDQUANTITATIVE
s#ANBEUSEDINTREATMENTFOLLOWUPANDASANINDICATOROF
viral reactivation
* Follow-up of Chronic Hepatitis:
Hepatitis A
VIDAS HAV IgM
30 tests
ref. 30 307
VIDAS Anti-HAV total
30 tests
ref. 30 312
VIDAS HBs Ag Ultra
60 tests
ref. 30 315
VIDAS HBs Ag Ultra Confirmation
30 tests
ref. 30 317
VIDAS Anti-HBs Total Quick
60 tests
ref. 30 238
VIDAS Anti-HBc Total II
60 tests
ref. 30 314
VIDAS HBc IgM II
30 tests
ref. 30 439
VIDAS HBe/Anti-HBe
30 tests
ref. 30 305
Hepatitis C
ref. 30 308
The VIDAS Anti-HCV assay combines a two-step enzyme
immunoassay sandwich method with a final fluorescent
detection. Proprietary recombinant Core, NS3 and NS4
antigens are used for the qualitative detection of anti-HCV
antibodies in serum or plasma.
s$ETECTSALL(#6GENOTYPES
s&ORPATIENTSWITHCLINICALSYMPTOMSORATRISKPOPULATIONS
* Pre- or Post Vaccination Immunity Control:
VIDAS Anti-HBc Total II
s%XCELLENTSENSITIVITYPROVIDEDWITHTHEINHIBITIONTECHNIQUE
* Screening during Pregnancy:
Incubation
4-7 weeks
,contact
Acute phase
Cure
4-12 weeks
years
clinical signs
HCV RNA
HCV Ag
Anti-HCV Ab
Increase in transaminase levels
VIDAS Anti-HCV
With all the benefits of VIDAS
Detection
(Core, NS3, NS4) IgG
s%ASYTOUSE
s2OBUSTANDRELIABLESYSTEM
s-AXIMUMmEXIBILITY
s#OSTEFFECTIVETESTPACKAGING
s)DEALFORROUTINECOMPLEMENTARYORSPECIALIZEDTESTING
Principle
Sandwich, ELFA
+ITSIZE
60 tests
VIDAS HBs Ag Ultra
VIDAS HBe/Anti-HBe
VIDAS Anti-HBs Total Quick
s#6AROUNDTHECUTOFFOF)5ML
Hepatitis B
60 tests
Incubation
* Diagnosis of recent infection:
* Control of previous immunity or vaccination:
VIDAS Anti-HCV
Anti-HBs
HBs Ag
HBe Ag
Incubation
Hepatitis C
Total anti-HBc Ab
Anti-HBs
* Rapid results
Calibration
Every 28 days
Run time
Around 40 min
Result interpretation
< 1: negative
≥ 1.00: positive
VIDAS quality you can trust
The solid performance of the VIDAS Anti-HCV assay in clinical
trials confirms the high level of quality you’ve come to
expect from VIDAS, for your peace of mind and the patient’s.
VIDAS HBs Ag Ultra
Diagnostic Specificity (95% Confidence Interval)
Blood donor population
(n=5,104)
99.61%
[99.40% - 99.76%]
Clinical Specificity (95% Confidence Interval)
Hospitalized patients
(n=200)
99.50%
[97.25% - 99.99%]
Diagnostic Sensitivity (95% Confidence Interval)
HCV+ / HIV negative patients
(n=254)
HCV+ / HIV positive patients
(n=61*)
HCV+ / (HIV unknown) patients
(n=124)
Total population
(n=439*)
100%
[98.56% - 100%]
98.36%
[91.20% - 99.96%]
100%
[97.07% - 100%]
99.77%
[98.74% - 99.99%]
*1 patient who was not detected using VIDAS Anti-HCV either had a low antibody level or was not
detected using equivalent method
REF 30 308
9300913 C - en - 2012/01
VIDAS® Anti-HCV (HCV)
VIDAS Anti-HCV is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of IgG
antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (heparin) using the ELFA technique (Enzyme
Linked Fluorescent Assay). The detection of these specific antibodies, in conjunction with other clinical information, aids
in the diagnosis of infection in persons with symptoms of hepatitis and in persons at risk for hepatitis C infection.
SUMMARY AND EXPLANATION
The Hepatitis C virus (HCV) discovered in 1989 using
advanced molecular biology techniques, was rapidly
found to account for the majority of those patients with
non-A non-B hepatitis. HCV represents a major worldwide
public health problem requiring global action for the
diagnosis, treatment and prevention of this infection (1).
HCV is primarily parenterally transmitted through direct
blood-to-blood contact between two people: use of
unsterilized injection devices and transfusion of
unscreened blood or blood products (2). The disease
frequently progresses to chronic hepatitis C (80%),
exposing patients to a greater risk of hepatic
complications such as cirrhosis or hepatocellular
carcinoma. (3).
The current standard of treatment for HCV is a
combination of two drugs: pegylated interferon and
ribavirin, but due to the high genetic variability of HCV (4),
it is still only partially effective: viral eradication in less
than 50% of patients infected with genotype 1 hepatitis C
virus against approximately 80% of patients infected with
genotype 2 or 3. New therapeutic options are under study
to offer more effective and safer personalized treatments
(5,6).
Diagnosis of patients infected with HCV can be performed
using two categories of virological tests: indirect tests, and
direct tests (7). Indirect serological tests are
third-generation enzyme immunoassays that detect
antibodies to HCV. The antigens used in the tests to
detect antibodies are from the structural and nonstructural regions of the HCV (8) (capsid, protein,
cofactors, polymerase, etc.). The presence of anti-HCV
antibodies indicates that an individual may have been
infected with HCV in the past or may have an ongoing
HCV infection. To confirm the presence of active HCV
infection, a positive serological test can be completed
using direct tests (e.g.: molecular assays that detect RNA
genomes). The results will be used to guide patient
management and determine the optimal duration of
treatment.
bioMérieux SA
The VIDAS Anti-HCV assay is a third-generation test
using antigens corresponding to the HCV core, NS3 and
NS4 proteins for the qualitative detection of anti-HCV
antibodies.
PRINCIPLE
The assay principle combines a two-step enzyme
immunoassay sandwich method with a final fluorescent
detection (ELFA).
®
The Solid Phase Receptacle (SPR ) serves as the solid
phase as well as the pipetting device. Reagents for the
assay are ready-to-use and are pre-dispensed in the
sealed reagent strips.
All of the assay steps are performed automatically by the
instrument. The reaction medium is cycled in and out of
the SPR several times.
During the first step, the sample is diluted, and then
cycled in and out of the SPR several times. The anti-HCV
antibodies present in the sample will bind to the antigens
representing the HCV core, NS3 and NS4 proteins coated
on the interior of the SPR. Unbound sample components
are washed away.
During the second step, mouse monoclonal anti-human
IgG antibodies in Fab form, conjugated to recombinant
alkaline phosphatase (yeast) are cycled in and out of the
SPR several times and will bind to the human Ig bound to
the molecules on the solid phase. Further wash steps
remove unbound components.
During the final detection step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR.
The conjugate enzyme catalyzes the hydrolysis of this
substrate into a fluorescent product (4-Methylumbelliferone) the fluorescence of which is measured at
450 nm. The intensity of the fluorescence is proportional
to the concentration of antibody present in the sample. At
the end of the assay, the results are automatically
calculated by the instrument in relation to the Standard S1
stored in memory, and then printed out.
English- 1
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
CONTENT OF THE KIT (60 TESTS) – RECONSTITUTION OF REAGENTS:
60 Strips HCV
STR
Ready-to-use.
60 SPRs HCV
(2 x 30)
SPR®
Ready-to-use.
Interior of SPRs coated with antigens representing the HCV core, NS3 and NS4
proteins.
HCV Positive control
1 x 1.9 ml (liquid)
C1
Pooled human serum or plasma* containing anti-HCV IgG in a phosphate buffer +
BSA + preservatives
Index: The confidence interval is indicated on the MLE card after the following
mention: "Control C1 (+) Test Value Range".
HCV Negative control
1 x 1.9 ml (liquid)
C2
Standard
1 x 1.9 ml (liquid)
S1
Phosphate buffer + BSA + preservatives
Index: The confidence interval is indicated on the MLE card after the following
mention: "Control C2 (-) Test Value Range".
Pooled human serum or plasma* containing anti-HCV IgG in a phosphate buffer +
BSA + preservatives
The confidence interval in "Relative Fluorescence Value (RFV)" is indicated on the
MLE card after the following mention: "Standard (S1) RFV Range".
1 MLE card (Master Lot Entry)
Specifications for the factory master data required to calibrate the test: to read the
MLE data, please refer to the User’s Manual
1 Package Insert provided in the kit or downloadable from www.biomerieux.com/techlib
* This product has been tested and shown to be negative for HBs surface antigen, and antibodies to HIV1 and HIV2. The product has been
inactivated. However, since no existing test method can totally guarantee their absence, this product must be treated as potentially
infectious. Therefore, usual safety procedures should be observed when handling.
The SPR
The interior of the SPR is coated during production with
the antigens representing the HCV core, NS3 and NS4
proteins. Each SPR is identified by the code "HCV". Only
remove the required number of SPRs from the pouch and
carefully reseal the pouch after opening.
The Strip
The strip consists of 10 wells covered with a labeled foil
seal. The label comprises a bar code which mainly
indicates the assay code, kit lot number and expiration
date. The foil of the first well is perforated to facilitate the
introduction of the sample. The last well of each strip is a
cuvette in which the fluorometric reading is performed.
The wells in the center section of the strip contain the
various reagents required for the assay.
Description of the HCV strip
Wells
Reagents
1
Sample well.
2
Sample diluent: TRIS buffered saline + Tween 20 + BSA + preservatives (600 µl)
3–4–5–7-8
Wash buffer: TRIS buffered saline + Tween 20 + preservatives (600 µl)
6
Conjugate: mouse monoclonal anti-human IgG antibodies conjugated to
recombinant ALP in Phosphate buffered saline + protein stabilizer + preservatives
(400 µl)
9
Reactive diluent: Phosphate buffered saline + preservative (400 µl)
10
Reading cuvette with substrate: 4-Methyl-umbelliferyl phosphate (0.6 mmol/l) +
diethanolamine (DEA*) (0.62 mol/l or 6.6%, pH 9.2) + 1 g/l sodium azide
(300 µl).
* IRRITANT reagent:
- R 36: Irritating to eyes.
- S 26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
For further information, refer to the Safety Data Sheet available on request.
bioMérieux SA
English - 2
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
MATERIALS AND DISPOSABLES REQUIRED BUT
NOT PROVIDED
- Pipette with disposable tip to dispense 100 µl.
- Powderless, disposable gloves.
- For other specific materials and disposables, please
refer to the Instrument User’s Manual.
- Instrument of the VIDAS family.
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use only.
• For professional use only.
• This kit contains products of human origin. No
known analysis method can totally guarantee the
absence of transmissible pathogenic agents. It is
therefore recommended that these products be
treated as potentially infectious and handled
observing the usual safety precautions (see
Laboratory biosafety manual - WHO - Geneva Latest edition).
• This kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the
animals does not totally guarantee the absence of
transmissible pathogenic agents. It is therefore
recommended that these products be treated as
potentially infectious and handled observing the usual
safety precautions (do not ingest or inhale).
®
• Do not use the SPR s if the pouch is pierced.
• Do not use visibly deteriorated STRs (damaged foil or
plastic).
• Do not use reagents after the expiration date indicated
on the box label.
• Do not mix reagents (or disposables) from different lots.
• Use powderless gloves, as powder has been reported
to cause false results for certain enzyme immunoassay
tests.
• Kit reagents contain sodium azide which can react with
lead or copper plumbing to form explosive metal azides.
If any liquid containing sodium azide is disposed of in
the plumbing system, drains should be flushed with
water to avoid build-up.
• The substrate in well 10 contains an irritant agent (6.6%
diethanolamine). Refer to the risk phrase “R” and the
precautions “S” above.
• Spills should be wiped up thoroughly after treatment
with liquid detergent or a solution of household bleach
containing at least 0.5% sodium hypochlorite. See the
User’s Manual for cleaning spills on or in the instrument.
Do not autoclave solutions containing bleach.
• The instrument should be regularly cleaned and
decontaminated (see the User’s Manual).
SPECIMENS
Specimen type and collection
Human serum or plasma
Types of tubes validated:
− Plain tube,
− Tube with lithium heparin,
− Tube with sodium heparin,
− Tube with lithium heparin and separation gel,
− Plastic tube with clot activator,
− Plastic tube with clot activator and separation gel.
The use of heat-inactivated sera has not been validate.
Note: Depending on the manufacturer, blood collection
tubes may contain materials and additives that could
generate different test results.
It is the responsibility of each laboratory to validate use of
these tubes in accordance with the manufacturer’s
recommendations for use.
Specimen preparation
Plain tubes: wait for samples to coagulate and centrifuge
according to the tube manufacturer’s recommendations to
eliminate fibrin.
Other
tubes:
follow
the
tube
manufacturer’s
recommendations for use.
Frozen-stored samples: after thawing, these samples
must be homogenized before analysis.
Sample-related interference
None of the following factors have been found to
significantly influence this assay:
- hemolysis (after spiking samples with hemoglobin: 0 to
300 µmol/l (monomer),
- lipemia (after spiking samples with lipids: 0 to 30 mmol/l
equivalent in triglycerides),
- bilirubinemia (after spiking samples with bilirubin: 0 to
220 mg/ml or 376 µmol/l).
However, it is recommended not to use samples that are
clearly hemolyzed, lipemic or icteric and, if possible, to
collect a new sample.
Do not inactivate samples.
Specimen stability
Serum and plasma samples separated from the clot, can
be stored at 2-8 °C in stoppered tubes for 7 days; if longer
storage is required, freeze the sera or plasma at
-25 ± 6°C.
Do not exceed 3 freeze/thaw cycles.
A study performed on samples frozen for 12 months,
showed that the quality of results is not affected.
STORAGE CONDITIONS
• Store the VIDAS Anti-HCV kit at 2-8°C.
• Do not freeze reagents.
• Store all unused reagents at 2-8°C.
• After opening the kit, check that the SPR pouch is
correctly sealed and undamaged. If not, do not use the
SPRs.
• To maintain stability of the remaining SPRs,
carefully reseal the pouch after use with the
desiccant inside and return the complete kit
to 2-8°C.
• If stored according to the recommended conditions, all
components are stable until the expiration date indicated
on the label.
bioMérieux SA
English- 3
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
INSTRUCTIONS FOR USE
For complete instructions, see the User’s Manual.
VIDAS PTC protocol data entry
When using the assay for the first time, and before
reading the MLE data, scan the bar code(s) (at the end
of the package insert) using the instrument’s external bar
code reader. This reading will allow VIDAS PTC protocol
data to be transferred to the instrument software for its
update. These data should only be read the first time the
assay is used.
Master lot data entry
Note: When using the assay for the first time, enter
the VIDAS PTC protocol (bar codes at the end of the
package insert) before reading the MLE data. If the
MLE data have been read before the VIDAS PTC
protocol, read the MLE data again.
Before each new lot of reagents is used, specifications (or
factory master calibration data) must be entered into the
instrument using the MLE data. If this operation is not
performed before initiating the tests, the instrument will
not be able to print results. The master lot data need only
be entered once for each lot.
It is possible to enter MLE data manually or automatically
depending on the instrument (refer to the User’s Manual).
Calibration
Calibration, using the standard provided in the kit, must be
performed upon receipt of a new lot of reagents after the
master lot data have been entered. Calibration should
then be performed every 28 days. This operation provides
instrument-specific calibration curves and compensates
for possible minor variations in assay signal throughout
the shelf-life of the kit.
The standard, identified by “S1”, must be tested in
duplicate (see User's Manual). The standard value must
be within the set RFV "Relative Fluorescence Value"
range. If this is not the case, recalibrate.
Procedure
1. Only remove the required reagents from the
refrigerator. They can be used immediately.
2. Use one “HCV” strip and one “HCV” SPR for each
sample, control or standard to be tested. Make sure
the storage pouch has been carefully resealed
after the required SPRs have been removed.
3. The test is identified by the "HCV" code on the
instrument. The standard must be identified by "S1",
and tested in duplicate. If the positive control is to be
tested, it should be identified by “C1”. If the negative
control is to be tested, it should be identified by “C2”.
4. If necessary, clarify samples by centrifugation.
5. Mix the standard, controls and samples using a vortextype mixer (for serum or plasma separated from the
pellet).
6. For this test, the standard, control, and sample
test portion is 100 µl.
9. Restopper the vials and return them to 2-8°C after
pipetting.
10. The assay will be completed within approximately
40 minutes. After the assay is completed, remove the
SPRs and strips from the instrument.
11. Dispose of the used SPRs and strips into an
appropriate recipient.
RESULTS AND INTERPRETATION
Once the assay is completed, results are analyzed
automatically by the computer. Fluorescence is measured
twice in the Reagent Strip’s reading cuvette for each
sample tested. The first reading is a background reading
of the substrate cuvette before the SPR is introduced into
the substrate. The second reading is taken after
incubating the substrate with the enzyme remaining on
the interior of the SPR. The RFV (Relative Fluorescence
Value) is calculated by subtracting the background
reading from the final result. This calculation appears on
the result sheet.
The results are automatically calculated by the instrument.
The patient RFV is interpreted as follows:
Test value = (patient RFV / standard RFV).
This test value and the interpretation are also included on
the result sheet. The interpretation depending on the test
value is as follows:
Test value (TV)
Interpretation
<1.00
negative
≥1.00
positive
All positive patient results must be verified in duplicate. If
at least one of the repeat values is positive, the patient
result is considered as positive. In that case, additional
tests should be performed (another immunoassay or HCV
marker) on the same sample or on a second one.
Note: In all cases, refer to current national guidelines
concerning HCV diagnosis.
Interpretation of VIDAS Anti-HCV test results should
be made taking into consideration the patient history
and the results of any other tests or hepatitis C
markers.
QUALITY CONTROL
One positive control and one negative control are included
in each VIDAS Anti-HCV kit.
These controls must be performed immediately after
opening a new kit to ensure that reagent performance has
not been altered. Each calibration must also be checked
using these controls. The instrument will only be able to
check the control values if they are identified by C1 and
C2.
Results cannot be validated if the control values deviate
from the expected values.
Note
It is the responsibility of the user to perform Quality
Control in accordance with any local applicable
regulations.
7. Insert the "HCV" SPRs and the “HCV” strips into the
instrument. Check to make sure the color labels with
the assay code on the SPRs and the Reagent Strips
match.
8. Initiate the assay as directed in the User’s Manual. All
the assay steps are performed automatically by the
instrument.
bioMérieux SA
English - 4
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
LIMITATIONS OF THE METHOD
For the diagnosis of HCV infection, the serological results
should be used and interpreted taking into account the
patient history, the clinical record, and further tests.
A negative test result does not exclude the possibility of
exposure to HCV or infection with HCV. Anti-HCV
antibodies may be undetectable in some stages of the
infection (acute phase of hepatitis or presence of a
serological scar) and in some clinical conditions
(immunosuppression) (7,9).
Interference may be encountered with certain sera
containing antibodies against reagent components.
This test has not been validated for use with any
specimen matrices other than human serum or plasma.
RANGE OF EXPECTED VALUES(1)
Hepatitis C has a worldwide prevalence of 2-3% that
varies according to country:
Region of the world
Anti-HCV prevalence (%)
Europe
2.3
Africa
3.2
Americas
1.5
Australia & Oceania
1.2
Asia
2.1
Middle East
4.7
Total
2.4
2. Clinical specificity for hospitalized patients
200 samples with a negative status were tested using the
VIDAS Anti-HCV assay.
Diagnostic specificity of the VIDAS Anti-HCV assay on
this population: 99.50%.
(95% confidence interval: 97.25% - 99.99%)
3. Diagnostic sensitivity
439 samples with a positive status, including 102 fresh
samples (collected ≤ 24 hours previously), were tested
using the VIDAS Anti-HCV assay.
Genotypes 1 to 6 were tested:
Genotype
1
2
3
4
(including non-a sub-types)
5
6
Number tested
21
21
23
22
6
2
Results on tested populations:
Population
PERFORMANCE
The following study results demonstrate the conformity of
VIDAS Anti-HCV to the Common Technical Specifications
of 98/79/CE Directive:
1. Specificity for blood donor population:
5104 blood donor samples (including 2904 fresh samples
with a negative status collected ≤ 24 hours previously)
obtained from 2 blood transfusion centers, were tested
using the VIDAS Anti-HCV assay.
Positive VIDAS
Anti-HCV
/total tested
HCV/HIVnegative patient
254/254
HCV/HIVpositive patient
60/61*
Patient with
unknown
HCV/HIV status
124/124
Total HCV
population
438/439*
Diagnostic
sensitivity observed
(95% confidence
interval)
100%
[98.56% - 100%]
98.36%
[91.20% - 99.96%]
100%
[97.07% - 100%]
99.77%
[98.74% – 99.99%]
* The patient who was not detected using VIDAS AntiHCV either had a low antibody level or was not detected
using equivalent methods.
Status
VIDAS Anti-HCV
Positive
Negative
Positive
0
20
Negative
0
5084
4. Sensitivity for seroconversion panels
Testing of 30 seroconversion panels demonstrated the
precocity of detection of the VIDAS Anti-HCV assay.The
results are comparable to those obtained using the most
sensitive methods.
Diagnostic specificity of the VIDAS Anti-HCV assay on
this population: 99.61%
(95% confidence interval: 99.40% - 99.76%)
bioMérieux SA
English - 5
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
5. Precision
The repeatability and reproducibility were determined at two sites and calculated according to the recommendations of
®
the CLSI documents EP5-A2 / EP12-A2.
Four human samples were tested in duplicate using two lots of reagents. Testing was performed twice a day for 10 days
on three instruments at one experimental site (N=120). Each reagent lot used a single calibration curve throughout the
study. Data from this study are summarized in the following table:
Sample 1
Sample 2
Sample 3
Sample 4
0.26
0.93
1.08
1.19
Sample ID /
Target value
Standard
deviation
CV (%)
Standard
deviation
CV (%)
Standard
deviation
CV (%)
Standard
deviation
CV (%)
Repeatability
0.01
5.6
0.04
4.3
0.05
4.8
0.06
4.7
Reproducibility
0.07
26.9
0.05
5.9
0.07
6.3
0.07
5.8
6. Cross-reactivity
273 samples from patients with a physiological status that can potentially interfere with the detection of hepatitis C
antibodies, were tested using VIDAS Anti-HCV. All of the samples were found to be negative with another EIA method
(except one CMV IgG+ sample). No disease-related interference was observed for VIDAS Anti-HCV.
HSV +
VZV +
EBV +
HIV +
CMV IgG +
LYME Ig+
HAV IgG +
HVB (HBcT +)
HVB (Ag HBs +)
Syphilis
Rubella IgG +
Toxoplasmosis IgG +
Rheumatoid factor
Anti-Nuclear Antibody
Anti-E. coli antibody
Anti-Pichia Antibody
Pregnant women**
VIDAS Anti-HCV
0/10
0/10
0/10
0/10
1/11*
0/10
0/10
0/8
0/10
0/10
0/10
0/10
0/10
0/10
0/10
0/10
0/114
* The reference EIA method also showed one false positive sample, but on a different sample.
** including 10 multipara.
bioMérieux SA
English - 6
®
VIDAS Anti-HCV (HCV)
9300913 C - en - 2012/01
WASTE DISPOSAL
Dispose of used or unused reagents as well as any other
contaminated disposable materials following procedures
for infectious or potentially infectious products.
It is the responsibility of each laboratory to handle waste
and effluents produced according to their nature and
degree of hazardousness and to treat and dispose of
them (or have them treated and disposed of) in
accordance with any applicable regulations.
INDEX OF SYMBOLS
Meaning
Symbol
Catalogue number
In Vitro Diagnostic Medical Device
Manufacturer
REFERENCES BIBLIOGRAPHIQUES
Temperature limitation
1. LAVANCHY D. Evolving epidemiology of hepatitis C virus Clin Microbiol Infect 2011; 17: 107-115.
2. ALTER MJ. Epidemiology of hepatitis C virus infection, World
J Gastroenterol 2007; 13(17): 2436-2441.
Use by
3. GURTSEVITCH VE. Human Oncogenic Viruses: Hepatitis B
and Hepatitis C Viruses and Their Role in
Hepatocarcinogenesis, Biochemistry (Moscow), 2008, 73(5):
504-513.
Batch code
Consult Instructions for Use
4. SIMMONDS P. et al. Consensus Proposals for a Unified
System of Nomenclature of Hepatitis C Virus Genotypes,
HEPATOLOGY 2005;42: 962-973.
Contains sufficient for <n> tests
5. VERMEHREN J, SARRAZIN C. New HCV therapies on the
horizon, Clin Microbiol Infect 2011; 17: 122–134.
6. WEBSTER D.P, KLENERMAN P., COLLIER J., JEFFERY K.
JM. Development of novel treatments for hepatitis C, Lancet
Infect Dis 2009; 9: 108-17.
7. CHEVALIEZ S. Virological tools to diagnose and monitor
hepatitis C virus infection, Clin Microbiol Infect 2011; 17:
116–121.
8. PENIN F, DUBUISSON, REY F-A, MORADPOUR D, ET
PAWLOTSKY JM. Structural Biology of Hepatitis C Virus,
HEPATOLOGY 2004; 39: 5-19.
9. THIO CL, NOLT KR, ASTEMBORSKI J, VLAHOV D,
NELSON KE et THOMAS DL. Screening for Hepatitis C Virus
in Human Immunodeficiency Virus-Infected Individuals,
Journal of clinical microbiology, Feb. 2000, 38(2): 575-577.
WARRANTY
bioMérieux disclaims all warranties, express or implied,
including any implied warranties of MERCHANTABILITY
AND FITNESS FOR A PARTICULAR USE. bioMérieux
shall not be liable for any incidental or consequential
damages.
IN NO EVENT SHALL BIOMERIEUX’S
LIABLITY TO CUSTOMER UNDER ANY CLAIM
EXCEED A REFUND OF THE AMOUNT PAID TO
BIOMERIEUX FOR THE PRODUCT OR SERVICE
WHICH IS THE SUBJECT OF THE CLAIM.
BIOMERIEUX, the blue logo, VIDAS and SPR are used, pending, and/or registered trademarks belonging to bioMérieux SA or one of its
subsidiaries.
CLSI is a trademark belonging to Clinical and Laboratory Standards Institute Inc.
Any other name or trademark is the property of its respective owner.
bioMérieux SA
Chemin de l’Orme
69280 Marcy-l'Etoile - France
RCS LYON 673 620 399
Tel. 33 (0)4 78 87 20 00
Fax 33 (0)4 78 87 20 90
www.biomerieux.com
0459
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