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Printed For Final Review: 10/10/03
ECO Number: 27341
4.1
PTH-MM II Calibrator 0: ready to use reagent
BSA-borate buffer with 0.05% sodium azide, gentamycin sulfate, Aprotinin, and other
stabilizers added; 10 mL. Mix thoroughly before using.
4.2
hPTH-MM II Calibrators (1-6): ready to use reagent
Synthetic hPTH [Tyr 43] 44-68 calibrators at nominal concentrations ranging from
31.25-1,200 pmol/L are prediluted in calibrator 0 containing 0.05% sodium azide and
other preservatives, 1.0 mL each. Exact concentration values are assigned with each
lot. Calibrators for this kit are made with synthetic hPTH 44-68. The kit calibrators
demonstrate commutability with patient samples when used with reagents and
operating procedure of this in vitro diagnostic test as recommended.
4.3
PTH-MM II Antiserum: ready to use reagent
Goat anti-PTH serum is diluted in BSA-borate buffer with 0.02% sodium azide added;
14 mL. Mix thoroughly before using.
4.4
I PTH-MM II (Red): ready to use reagent
125
Synthetic hPTH [Tyr 43] 44-68 is labeled with iodine-125 and diluted in BSA-borate-
EDTA buffer with 0.02% sodium azide, thimerosal and red dye; 14 mL. Mix thoroughly
before using.
4.5
PTH-MM II Precipitating Complex (DAG-PPT): ready to use reagent
Donkey anti-goat serum pre-precipitated with normal goat serum and polyethylene
glycol (PEG) is diluted in BSA-borate buffer with 0.1% sodium azide added; 35 mL. Mix
THOROUGHLY until the suspension appears homogeneous.
4.6
PTH-MM II Control Serum (Level 1 and Level 2): lyophilized reagent
Human plasma is spiked, if necessary, with the appropriate amount of hPTH 44-68 to
obtain a concentration within a specified range.
stabilizers are added. Reconstitute each vial with 1.0 mL of purified water; mix and
allow to stand for 15-20 minutes until the contents are completely dissolved. Mix
thoroughly and treat as an unknown sample. Ranges for each lot are printed on the
control vials. Store the reconstituted controls at –15°C.
5.
WARNING AND PRECAUTIONS
FOR IN VITRO DIAGNOSTIC USE.
Not for internal or external use in humans or animals.
REAGENTS CONTAINING HUMAN SOURCE MATERIAL
Treat as potentially infectious.
Each serum/plasma donor unit used in the preparation of this product has been tested
by a U.S. FDA approved method and found non-reactive for the presence of HBsAg,
antibody to HCV, and antibody to HIV 1/2. While these methods are highly accurate,
they do not guarantee that all infected units will be detected. This product may also
contain other human source material for which there is no approved test. Because no
known test method can offer complete assurance that hepatitis B virus (HBV), hepatitis
C virus (HCV), Human Immunodeficiency Virus (HIV), or other infectious agents are
absent, all products containing human source material should be handled in
accordance with good laboratory practices using appropriate precautions as described
in the U.S. Centers for Disease Control and Prevention/National Institutes of Health
Manual, "Biosafety in Microbiological and Biomedical Laboratories," 4
or current edition.
REAGENTS CONTAINING SODIUM AZIDE
CAUTION: Some reagents in this kit contain sodium azide. Sodium azide may react
with lead or copper plumbing to form highly explosive metal azides. On disposal, flush
with a large volume of water to prevent azide build-up. For further information, refer to
"Decontamination of Laboratory Sink Drains to Remove Azide Salts," in the Manual
Guide-Safety Management No. CDC-22 issued by the Centers for Disease Control and
Prevention, Atlanta, GA, 1976.
10:45 AM
0.1% sodium azide and other
2
th
ed., May 1999
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