OSOM hCG Urine Control Set ®

OSOM hCG Urine Control Set ®
OSOM® hCG Urine Control Set
Catalog #134
INTENDED USE
The OSOM hCG Urine Control Set is intended for in
vitro diagnostic use in quality control testing with OSOM
hCG-Urine, OSOM Card Pregnancy and the OSOM
hCG Combo Test.
SUMMARY
The OSOM hCG Urine Control Set provides a Negative
Control and two levels of Positive Controls in saline.
The Positive Controls contain purified hCG; the
Negative Control is free of detectable hCG. When used
for quality control in OSOM hCG-Urine, OSOM Card
Pregnancy and the OSOM hCG Combo Test, the
Controls are useful as an aid in verifying test and
operator performance.
MATERIALS PROVIDED
OSOM hCG Urine Control - Negative, 10 mL/vial,
•
contains saline with 0.2 % sodium azide
•
OSOM hCG Urine Control – Positive I, 10 mL/vial,
contains 50-100 mIU/mL hCG (3rd IS) in saline
with 0.2 % sodium azide
OSOM hCG Urine Control – Positive II,
•
10 mL/vial, contains 500-1000 mIU/mL hCG
(3rd IS) in saline with 0.2 % sodium azide
Warning: Contains Azide
MATERIALS REQUIRED BUT NOT PROVIDED
OSOM hCG-Urine, OSOM Card Pregnancy or
•
OSOM hCG Combo Test
•
Clock or Timer
WARNINGS AND PRECAUTIONS
1.
For In Vitro Diagnostic Use
2.
DO NOT use the Controls beyond the expiration
date.
3.
The Controls contain sodium azide which may
react with lead or copper plumbing to form
potentially explosive metal azide. Large
quantities of water must be used to flush
discarded Controls down a sink.
4.
Potential biohazard. Handle as if potentially
infectious. Handle this product according to
established good laboratory practices using
appropriate precautions.1-3
STORAGE
The OSOM hCG Urine Control Set must be stored
refrigerated (2°-8°C; 36°- 46°F).
Do not freeze
•
Tightly seal the vials after use to prevent
•
evaporation.
•
Store vials upright to prevent spills and leakage.
Pregnancy or OSOM hCG Combo Test (urine
procedure). Read the procedural instructions from
the assay product insert prior to testing.
LIMITATIONS
1.
Obtaining accurate results from quality control
material requires good laboratory practices.
2.
Erroneous results can occur from improper
storage, inadequate mixing, or sample handling
errors associated with assay procedures.
3.
Do not use the quality control material if there is
visible evidence of microbial growth in the vial.
For more information about procedural limitations, refer
to the assay product insert.
EXPECTED RESULTS
The Negative Control should yield a negative result as
described in the Expected Results section of the assay
product insert.
The Positive Controls should yield a positive result as
described in the Expected Results section of the assay
product insert.
DISPOSING OF MATERIALS
Dispose of hazardous or biologically contaminated
materials according to your institution's practices.
Discard all materials in a safe and acceptable manner
that is in compliance with all country, state, and local
requirements.
REFERENCES
1. Centers for Disease Control. 1988. Update:
Universal Precautions for Prevention of
Transmission of Human Immunodeficiency Virus,
Hepatitis B virus and Other Bloodborne Pathogens
in Healthcare Settings. MMWR, 37: 377-382, 387,
388.
2. National Committee for Clinical Laboratory
Standards. Protection of laboratory workers from
instrument biohazards and infectious disease
transmitted by blood, body fluids, and tissue;
approved guideline. NCCLS Document M29-A.
Wayne (PA): NCCLS; 1997 Dec. 90p.
3. Federal Occupational Safety and Health
Administration, Bloodborne Pathogens Standard, 29
CFR 1910.1030.
ASSISTANCE
For technical assistance, call Genzyme Diagnostics
Technical Service at 800-332-1042.
STABILITY
Unopened and opened vials stored at 2°- 8°C
•
(36°- 46°F) are stable until the expiration date
printed on the vial and box label.
INSTRUCTIONS FOR USE
1.
Bring Controls to room temperature prior to use.
2.
Invert Controls several times prior to use.
3.
Use the OSOM hCG Urine Controls as you would
a patient sample in accordance with the
procedure of OSOM hCG-Urine, OSOM Card
OSOM® is a registered trademark of Genzyme Corporation.
Cambridge, MA 02139-1562
TEL 800-332-1042
617-252-7760
FAX 617-252-7759
www.genzymediagnostics.com
313-5, 11/06
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement