26.11.2014 Views

Reagent Kit - Biokit

Reagent Kit - Biokit

Reagent Kit - Biokit

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-1474<br />

Date: 27-07-05 Rev.: 02<br />

Pag.: 1 of 3<br />

1. Identification of preparation<br />

Product name: bioblot HCV<br />

2. Composition/information on ingredients<br />

<strong>Kit</strong> components:<br />

Nitrocellulose strips: Strips of nitrocellulose incorporated with HCV recombinant structural and non-structural<br />

antigens and two serum addition control (anti-human IgG and human IgG) bands.<br />

Concentrate conjugate: Goat anti-human IgG antibodies conjugated with alkaline phosphatase. Contains<br />

sodium azide.<br />

Negative control: Inactivated human serum negative for HCV, HIV-1, HIV-2 antibodies and hepatitis B surface<br />

antigen (HBsAg). Contains sodium azide and thimerosal.<br />

Positive control: Inactivated human serum containing a high titre of HCV antibodies. Negative for hepatitis B<br />

surface antigen (HBsAg) and for HIV-1, HIV-2 and HTLV-I/II antibodies. Contains sodium azide and thimerosal.<br />

Washing solution: Concentrate Tris buffer containing Tween 20 and thimerosal.<br />

Concentrate blotting buffer: Concentrate Tris buffer. Contains heat inactivated normal goat serum and<br />

thimerosal.<br />

Substrate: 5-bromo-4-chloro-3-indolyl-phosphate (BCIP) and nitroblue tetrazolium (NBT) solution.<br />

Blotting powder: Powdered non-fat dry milk<br />

3. Hazards identification<br />

Positive and negative controls contain Sodium Azide (NaN 3) and Thimerosal.<br />

Sodium azide CAS-Nº: 26628-22-8 EINECS-Nº: 247-852-1<br />

Thimerosal CAS-Nº: 54-64-8 EINECS-Nº: 200-210-4<br />

Harmful.<br />

Concentrate conjugate contains Sodium Azide (NaN 3).<br />

Sodium azide CAS-Nº: 26628-22-8 EINECS-Nº: 247-852-1<br />

Harmful.<br />

Concentrate blotting buffer and washing solution contain Thimerosal.<br />

Thimerosal CAS-Nº: 54-64-8 EINECS-Nº: 200-210-4<br />

Harmful.<br />

Substrate contains 5-bromo-4-chloro-3-indolyl-phosphate and nitroblue tetrazolium.<br />

5-bromo-4-chloro-3-indolyl-phosphate CAS-Nº: 102185-33-1 EINECS-Nº: None<br />

Nitroblue tetrazolium CAS-Nº: 298-83-9 EINECS-Nº: 206-067-4<br />

Harmful.<br />

4. First aid measures<br />

Inhalation: Remove from exposure. If breathing is difficult, obtain medical attention if necessary.<br />

Eye contact: Rinse immediately with water for at least 15 minutes separating eyelid.<br />

Skin contact: Wash off thoroughly with plenty of water. Remove and wash contaminated clothing.<br />

Ingestion: Obtain medical attention<br />

5. Fire-fighting measures<br />

Extinguishing media: Use media in adaptation to materials stored in the immediate neighbourhood.<br />

Special firefighting procedures: Wear self-contained breathing apparatus and protective clothing to prevent contact with<br />

skin and eyes.<br />

6. Accidental release measures<br />

After spillage: Wipe up spills with inert absorbant tissues and place in a suitable container. Use protective gloves.


BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-1474<br />

Date: 27-07-05 Rev.: 02<br />

Pag.: 2 of 3<br />

7. Handling and storage<br />

Handling: The normal precautions for handling chemicals must be observed. Wash hands after handling.<br />

Storage: Between +2ºC to 8ºC.<br />

8. Exposure controls/personal protection<br />

Respiratory protection: Good local ventilation.<br />

Eye protection: Protective glasses.<br />

Hand protection: One-way gloves (latex or plastic).<br />

Use protective lab coat. Is recommended the use of safety pipette device.<br />

9. Physical and chemical properties<br />

Appearance:<br />

Nitrocellulose strips: white plastic strip<br />

Concentrate conjugate: colourless liquid<br />

Negative control: straw liquid<br />

Positive control: straw liquid<br />

Washing solution: straw liquid<br />

Concentrate blotting buffer: yellowish liquid<br />

Substrate: light yellow liquid<br />

Blotting powder: yellowish powder<br />

Odour: Odourless<br />

Boiling point: N/A<br />

Melting point: N/A<br />

Flash point: N/A<br />

Ignition temperature: N/A<br />

Explosion limits: N/A<br />

Vapour pressure: N/A<br />

Density: N/A<br />

Viscosity: N/A<br />

Solubility in water: soluble<br />

10. Stability and reactivity<br />

Conditions and materials to avoid: N/A<br />

Hazardous reactions: N/A<br />

Hazardous descomposition products: N/A<br />

11. Toxicological information<br />

Data not available.<br />

12. Ecological information<br />

Data not available.<br />

13. Disposal considerations<br />

Remains of samples, reagents and controls should be collected in a recipient for this purpose and autoclaved 1 hour at<br />

121ºC.<br />

Observe all Federal, State and local laws.<br />

14. Transport information<br />

Specials requirements: None


BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-1474<br />

Date: 27-07-05 Rev.: 02<br />

Pag.: 3 of 3<br />

15. Regulatory information<br />

According to 1999/45/EC Directive and 91/155/EEC Directive and following modifications.<br />

Positive and negative controls:<br />

Hazard symbol Xn Harmful<br />

R-phrases<br />

R22<br />

Harmful if swallowed.<br />

Concentrate conjugate:<br />

Hazard symbol Xn Harmful<br />

R-phrases<br />

R22<br />

Harmful if swallowed.<br />

Concentrate blotting buffer and washing solution:<br />

Hazard symbol Xn Harmful<br />

R-phrases<br />

R22<br />

Harmful if swallowed.<br />

Substrate:<br />

Hazard symbol Xn Harmful<br />

R-phrases<br />

R20/21/22<br />

Harmful by inhalation, in contact with skin and if swallowed.<br />

16. Other information<br />

Intended use: Qualitative enzyme immunoassay for the detection of antibodies to hepatitis C virus (HCV) in human serum<br />

or plasma. It is intended for use as a more specific supplemental test on human serum or plasma specimens found<br />

repeatedly reactive using screening procedures such as ELISA.<br />

For IN VITRO diagnostic use.<br />

Some reagents in this kit contain sodium azide as a preservative. Sodium azide has been reported to form lead or copper<br />

azide in laboratory plumbing which may explode on percusion. Use proper disposal procedures.<br />

Each donor unit used in the preparation of the controls of this kit was tested by an approved method for the presence of<br />

the antibodies to HIV and HCV as well as for HBsAg and found to be negative. WARNING: Because no test method can<br />

offer complete assurance that HIV, HCV, HBsAg or other infectious agents are absent, the controls of this kit should be<br />

handled carefully.<br />

The above information is believed to be correct, but does not purpose to be all inclusive and should be used only as a<br />

guide. BIOKIT S.A. shall not be held for any damage resulting from handling or use of the product.

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!