Item Brochure

3076-3, 06/15
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, OSOM hCG
Combo Test and the OSOM Ultra hCG Combo Test.
SUMMARY
The OSOM hCG Urine Control Set provides 1 Negative
Control and 1 Positive Control in saline. The Positive
Control contains purified hCG; the Negative Control is
free of detectable hCG. When used for quality control
in OSOM hCG-Urine, OSOM Card Pregnancy, OSOM
hCG Combo Test and the OSOM Ultra 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, 10 mL/vial,
contains 50-100 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, OSOM
hCG Combo Test or OSOM Ultra hCG Combo Test
 Clock or Timer
WARNINGS AND PRECAUTIONS
 For In Vitro Diagnostic Use
 DO NOT use the Controls beyond the expiration
date.
 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.
 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.
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 Pregnancy, OSOM
hCG Combo Test (urine procedure) or the OSOM
Ultra hCG Combo Test (urine procedure).
4. Read the procedural instructions from the assay
product insert prior to testing.
LIMITATIONS
 Obtaining accurate results from quality control
material requires good laboratory practices.
 Erroneous results can occur from improper storage,
inadequate mixing, or sample handling errors
associated with assay procedures.
 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 Control 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 assistance, call Sekisui Diagnostics Technical
Service at 800-332-1042.
Manufactured by: Sekisui Diagnostics, LLC.
6659 Top Gun St. San Diego, CA 92121 USA
TEL [phone]
TEL: [phone]
www.sekisuidiagnostics.com
OSOM

is a registered U.S. trademark of Sekisui Diagnostics, LLC.
©2015, Sekisui Diagnostics, LLC – All rights reserved.