Item Brochure

3077-2, 04/15
OSOM

hCG Serum Control Set
Catalog #138
INTENDED USE
The OSOM hCG Serum Control Set is intended for in vitro
diagnostic use in quality control testing with the OSOM
hCG Combo Test and the OSOM Ultra hCG Combo Test.
SUMMARY
The OSOM hCG Serum Control Set provides a Negative
Control and a Positive Control in horse serum. The
Positive Control contains purified hCG; the Negative
Control is free of detectable hCG. When used for quality
control in the 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 Serum Control - Negative, 5 mL/vial,
contains horse serum with 0.2 % sodium azide
 OSOM hCG Serum Control - Positive, 5 mL/vial,
contains approximately 50 mIU/mL hCG (3rd IS) in
horse serum with 0.2 % sodium azide
Warning: Contains Azide
MATERIALS REQUIRED BUT NOT PROVIDED
 OSOM hCG Combo Test (Catalog #124)
 OSOM Ultra hCG Combo Test (Catalog #1004)
 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 Serum 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 Serum Controls as you would a
patient sample in accordance with the serum
procedure of the OSOM hCG Combo or the OSOM
Ultra hCG Combo Test. 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 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]
www.sekisuidiagnostics.com
©2015, Sekisui Diagnostics, LLC – All rights reserved.