PLATELIA CANDIDA Ab PLUS Negative and Positive Controls. Quality Control Human Sera

Transcription

1 PLATELIA CANDIDA Ab PLUS Negative and Positive Controls Quality Control Human Sera

2 CONTENTS 1. INTENDED USE INDICATIONS FOR USE REAGENTS WARNING FOR USERS PRECAUTIONS FOR USERS REAGENT PREPARATION AND STORAGE PROCEDURE INTERPRETATION OF RESULTS EXPECTED VALUES LIMITATIONS OF THE PROCEDURE PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY...6 2

3 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 N o (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 Presentation 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 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 3

4 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 4

5 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. 5

6 6 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 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 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 Management of invasive candidiasis and candidemia in adult non-neutropenic intensive care unit patients: Part I. Epidemiology and diagnosis. Intensive Care Med. 35: p Oliveri, S., Trovato, L., Betta, P., Romeo, M.G., Nicoletti, G Experience with the Platelia Candida ELISA for the diagnosis of invasive candidiosis in neonatal patients. Clinical Microbiology and Infection 14 (4): p Verduyn Lunel, F.M., Donnelly, J.P., van der Lee, H. A. L., Blijlevens, N.M. A.,Verweij, P. E Circulating Candidaspecific anti-mannan antibodies precede invasive candidiasis in patients undergoing myelo-ablative chemotherapy. Clin. Microbiol. Infect. 15(4): p

7 32

8 33

9 bio-rad 3, boulevard Raymond Poincaré Marnes-la-Coquette France Tel. : +33 (0) /2011 Fax.: +33 (0) Printed in France