PLATELIA™ CANDIDA Ab PLUS
Negative and Positive Controls
48
Quality Control Human Sera
62787
CONTENTS
1.
INTENDED USE................................................................................3
2.
INDICATIONS FOR USE...................................................................3
3.REAGENTS.......................................................................................3
4.
WARNING FOR USERS...................................................................4
5.
PRECAUTIONS FOR USERS...........................................................5
6.
REAGENT PREPARATION AND STORAGE....................................5
7.PROCEDURE....................................................................................5
8.
INTERPRETATION OF RESULTS....................................................5
9.
EXPECTED VALUES .......................................................................5
10.
LIMITATIONS OF THE PROCEDURE ............................................5
11. PERFORMANCE CHARACTERISTICS............................................6
12.BIBLIOGRAPHY...............................................................................6
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1. INTENDED USE
Platelia™ Candida Ab Plus -Negative Control is a human serum, non-reactive
for anti-mannan antibody, for use as a quality control serum to monitor the
precision of laboratory testing procedure for the detection of anti-Candida
mannan antibodies, using Platelia™ Candida Ab Plus assay.
Platelia™ Candida Ab Plus - Positive Control is a human serum, reactive
for anti-mannan antibody, for use as a quality control serum to monitor the
precision of laboratory testing procedure for the detection of anti-Candida
mannan antibodies, using Platelia™ Candida Ab Plus assay.
2. INDICATIONS FOR USE
The use of quality control materials is indicated as an objective assessment
of the precision of methods and techniques used and is an integral part of
good laboratory practices.
3.REAGENTS
Platelia™ Candida Ab Plus-Negative and Positive Controls:
Product No 62787 (48 Tests)
Store the kit at 2-8°C. Bring all reagents to room temperature (18-25°C) for
at least 30 minutes before use. Return all reagents to 2-8°C immediately
after use.
Reagents are supplied in sufficient quantity to perform 48 tests.
Labeling
Reagent type
Negative Control Serum:
• Human serum, non-reactive for antimannan antibodies
• Negative for anti-HIV-1, anti-HIV-2,
anti-HCV antibodies and HBs Ag
• Preservative: <1.5% ProClin™ 300
Presentation
2 x 350 µl
Ready to use
Positive Control Serum:
• Human serum, reactive for anti-mannan
antibodies
2 x 350 µl
• Negative for anti-HIV-1, anti-HIV-2,
Ready to use
anti-HCV antibodies and HBs Ag
• Preservative: <1.5% ProClin™300
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4. WARNING FOR USERS
1.For in vitro diagnostic use.
2.For professional use only.
3.The Negative and Positive Controls are manufactured from human serum
that has been tested and found to be non-reactive for HBs Ag and
antibodies to HIV-1, HIV-2 and HCV with CE marked tests. However, all
reagents should be handled as though capable of transmitting infection.
All tests should be conducted in accordance with the OSHA Standard on
Bloodborne Pathogens, Biosafety Level 2 or other appropriate biosafety
practices.
4.Wear protective clothing, including lab coat, eye/face protection and
disposable gloves (synthetic, non-latex gloves are recommended) and
handle the kit reagents and patient samples with the requisite Good
Laboratory Practices. Wash hands thoroughly after performing the test.
5.Do not pipette by mouth.
6.Do not smoke, drink, or eat in areas where specimens or kit reagents are
being handled.
7.Avoid splashing reagents.
8.Biological spills not containing acid should be wiped thoroughly with
an effective disinfectant. Disinfectants that can be used include (but
are not limited to) a solution of 10% bleach (0.5% solution of sodium
hypochlorite), 70% ethanol, or 0.5% Wescodyne Plus™. Materials used
to wipe up spills may require biohazardous waste disposal.
CAUTION: Do not place solutions containing bleach in the autoclave.
9.Spills containing acid should be appropriately absorbed (wiped up) or
neutralized with sodium bicarbonate, and the area rinsed and wiped dry; if
it contained biohazardous material, wipe the area with one of the chemical
disinfectants.
10. Dispose of all controls and materials used to perform the test as though
they contain an infectious agent. Laboratory chemical and biohazardous
wastes must be handled and discarded in accordance with all local,
regional and national regulations.
11. Caution: the reagents contain ProClin™ 300 < 1.5%.
For risks and security recommendations refer to the table at the end of
the package insert.
Risk(R) and Safety(S) phrases (2001/59/EC) relaying specific information
about a hazardous preparation.
12.The Material Safety Data Sheet (MSDS) is available upon request or on
www.bio-rad.com.
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5. PRECAUTIONS FOR USERS
1.Do not use kit or any kit reagents after the stated expiration date.
2.Bring all reagents to room temperature (18-25°C) for at least 30
minutes before use.
3.Mix thoroughly the controls before use.
4.For manual pipetting of controls, use individual pipette tips to prevent
carryover of samples.
6. REAGENT PREPARATION AND STORAGE
Negative Control Serum, Positive Control Serum
These reagents are liquid and ready to use.
After opening, these reagents stored at +2-8°C are stable for 8 weeks in the
absence of contamination.
7.PROCEDURE
The Negative and The Positive Controls have to be handled as patient
samples , strictly following the technical procedure mentioned in the package
insert of the Platelia™ Candida Ab Plus assay (cat. # 62785).
Bring the Negative and the Positive Controls to room temperature (18-25°C)
for at least 30 minutes before use.
Gently swirl the content of the vials before sampling.
8. INTERPRETATION OF RESULTS
The anti-mannan antibody concentration of the Negative and the Positive
Controls, reported as AU (Arbitrary Units) /ml, can be determined from the
calibration curve (ref. to Platelia™ Candida Ab Plus package insert, section 12).
9. EXPECTED VALUES
•
: < 5 AU/ml
•
: ≥ 10 AU/ml
Platelia™ Candida Ab Plus-Negative Control was formulated to produce
negative results and Platelia™ Candida Ab Plus-Positive Control was
formulated to produce positive results.
If the concentrations of the Negative and/or Positive Controls do not meet
the expected values, a procedural error has to be checked. Then a new
sample has to be tested.
10. LIMITATIONS OF THE PROCEDURE
1.If there is any evidence of microbial contamination or excessive turbidity
in the Negative or Positive Controls, discard the vial.
2.This product is not intended for use as a calibrator.
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3. A false positive result may be obtained for the Negative Control if the
Negative Control and Platelia™ Candida Ab Plus kit reagents are not
added as indicated in the insert. In the event of procedural error, a new
sample of the Negative Control must be tested.
4.A false negative result may be obtained for the Positive Control if the
Positive Control and Platelia™ Candida Ab Plus kit reagents are not
added as indicated in the insert. In the event of procedural error, a new
sample of the Positive Control must be tested.
5.Contamination of wells containing Negative Control samples by wells
containing Positive Control samples or positive patient samples may
occur if the contents of a well overflow into another well due to clumsy
handling of the microplate or due to poor pipetting technique when adding
reagents.
6.The performance characteristics of this product have not been evaluated
using other test procedure than Platelia™ Candida Ab Plus assay
procedure.
11.PERFORMANCE CHARACTERISTICS
For intra-assay and inter-assay precision, refer to Platelia™ Candida Ab Plus
package insert: section 15: “Performance Characteristics, A. Reproducibility
studies”.
12.BIBLIOGRAPHY
1.Ellis, M., Al-Ramadi, B., Bernsen, R., Kristensen, J., Alizadeh,
H., Hedstrom,U. 2009. Prospective evaluation of mannan and antimannan antibodies for diagnosis of invasive Candida infections in patients
with neutropenic fever. Journal of medical microbiology 58(5): p. 606-615.
2.Guery, B.P., Arendrup, M.C., Auzinger, G., Azoulay, E., Borges
Sá, M.,Johnson, E.M., Müller, E., Putensen, C., Rotstein, C.,
Sganga, G., Venditti,M., Zaragoza Crespo, R., Kullberg,
B.J. 2009. Management of invasive candidiasis and candidemia in adult
non-neutropenic intensive care unit patients: Part I. Epidemiology and
diagnosis. Intensive Care Med. 35: p.55–62.
3.Oliveri, S., Trovato, L., Betta, P., Romeo, M.G., Nicoletti, G.
2008. Experience with the Platelia™ Candida ELISA for the diagnosis
of invasive candidiosis in neonatal patients. Clinical Microbiology and
Infection 14 (4): p. 377-397.
4.Verduyn Lunel, F.M., Donnelly, J.P., van der Lee, H. A. L.,
Blijlevens, N.M. A.,Verweij, P. E. 2009. Circulating Candidaspecific anti-mannan antibodies precede invasive candidiasis in patients
undergoing myelo-ablative chemotherapy. Clin. Microbiol. Infect. 15(4): p.
380-386.
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11/2011
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