Siemens Coat-A-Count TSH IRMA Manual Del Usuario página 3

Do not use reagents beyond their
expiration dates.
Some components supplied in this kit may
contain human source material and/or
other potentially hazardous ingredients
which necessitate certain precautions.
Follow universal precautions, and handle
all components as if capable of
transmitting infectious agents. Source
materials derived from human blood were
tested and found nonreactive for syphilis;
for antibodies to HIV 1 and 2; for hepatitis
B surface antigen; and for antibodies to
hepatitis C.
Sodium azide, at concentrations less than
0.1 g/dL, has been added as a
preservative. On disposal, flush with large
volumes of water to prevent the buildup of
potentially explosive metal azides in lead
and copper plumbing.
Water: Use distilled or deionized water.
Radioactivity
A copy of any radioisotope license
certificate (Specific or General) issued to a
US customer must be on file with Siemens
Healthcare Diagnostics before kits or
components containing radioactive
material can be shipped. These
radioactive materials may be acquired by
any customer with the appropriate Specific
license. Under a General license these
radioactive materials may be acquired
only by physicians, veterinarians in the
practice of veterinary medicine, clinical
laboratories and hospitals — and strictly
for in vitro clinical or laboratory tests not
involving external or internal
administration of the radioactive material
or its radiation to human beings or other
animals. Its acquisition, receipt, storage,
use, transfer and disposal are all subject
to the regulations and a (General or
Specific) license of the U.S. Nuclear
Regulatory Commission or a State with
which the NRC has entered into an
agreement for the exercise of regulatory
control.
Handle radioactive materials according to
the requirements of your General or
Specific license. To minimize exposure to
radiation, the user should adhere to
guidelines set forth in the National Bureau
of Standards publication on the Safe
Handling of Radioactive Materials
(Handbook No. 92, issued March 9, 1964)
Coat-A-Count TSH IRMA (PIIKTS-8, 2010-11-04)
and in subsequent publications issued by
State and Federal authorities.
Wipe up spills promptly and
decontaminate affected surfaces. Avoid
generation of aerosols. Dispose of solid
radioactive waste according to license
requirements. General licensees (holders
of NRC Form 483) may dispose of solid
radioactive waste as nonradioactive
waste, after removing labeling. Specific
licensees (NRC Form 313) should refer to
Title 10, Code of Federal Regulations,
Part 20. Licensees in Agreement States
should refer to the appropriate regulations
of their own state. General licensees may
dispose of liquid radioactive waste of the
type contained in this product through a
laboratory sink drain. Licensees must
remove or deface labels from empty
containers of radioactive materials before
disposal of solid waste. Specific licensees
may dispose of small quantities of liquid
radioactive waste of the type used in this
product through a laboratory sink drain.
Refer to the appropriate regulations
applicable to your laboratory.
Materials Supplied – Initial
Preparation
TSH Ab-Coated Tubes (ITS1)
Polystyrene tubes coated with murine
monoclonal antibodies to TSH and
packaged in zip-lock bags. Store
refrigerated and protected from moisture,
carefully resealing the bags after opening.
Stable at 2–8°C for one year from the date
of manufacture.
IKTS1: 100 tubes. IKTS5: 500 tubes.
IKTSX: 1000 tubes.
125
I TSH Ab (ITS2)
Iodinated anti-TSH goat polyclonal
antibody, with preservative. The reagent is
supplied in liquid form, ready to use. Each
vial contains 5.5 mL. Stable at 2–8°C for
30 days after opening, or until the
expiration date marked on the label.
Color: red.
IKTS1: 2 vials. IKTS5: 10 vials.
IKTSX: 20 vials.
TSH Calibrators (TSI3–9,X)
Eight vials, labeled A through H, of
lyophilized TSH calibrators in an equine
serum/buffer matrix, with preservative
(gentamicin). 30 minutes before use,
3