Hemoglobin Controls,
Cat. No. 0330
For Information Use Only
For Use as Human Hemoglobin Controls in
Quantitative Cyanmethemoglobin
Procedures
Summary and Principle
Controls, when assayed with actual specimens, help a
laboratory evaluate whether a given procedure is performing
with acceptable accuracy and precision. Stanbio
controls, Cat No. 0330, are prepared by using human
hemoglobin and include a preservative for long shelf life.
The product is provided in a lyophilized state; when
reconstituted the resulting whole blood provides three
levels (low, mid-range, elevated) of hemoglobin, as indicated
for the particular lot number.
Reagents
Hemoglobin Control - Level I (Low), Cat. No. 0331 (2mL)
Lyophilized hemolysate prepared from packed human erythrocytes
with preservatives. Contains hemoglobin at low levels.
Hemoglobin Control - Level II (Mid-Range), Cat. No. 0332 (2mL)
Lyophilized hemolysate prepared from packed human erythrocytes
with preservatives. Contains hemoglobin at normal levels.
Hemoglobin Control - Level III (Elevated), Cat. No. 0333 (2mL)
Lyophilized hemolysate prepared from packed human erythrocytes
with preservatives. Contains hemoglobin at elevated levels.
Precautions: For In Vitro Diagnostic Use.
This human blood product has been tested by an FDA
approved method and found non-reactive for the presence
of HBsAg and antibody to HIV. While these methods
are highly accurate, no test can offer complete assurance
that infectious agents are absent. This material, as well as
all patient samples, should be handled as though capable
of transmitting infectious disease. The United States Food
and Drug Administration recommends such samples be
handled as Center for Disease Control's Biosafety Level 2.
Reconstitution: Remove aluminum seal and rubber stopper
carefully to avoid loss of contents. Using a volumetric
pipet, add 2.0 mL of deionized or distilled water to vial.
Replace rubber stopper and allow to stand 5 - 10 minutes.
Mix vial until contents are completely dissolved.
Storage and Stability: Lyophilized controls are stable
until expiration date, when stored at 2-8oC with seals
intact. Reconstituted controls are stable 60 days at 2-8oC
and 120 days at -20oC. Reconstituted product may be
aliquoted and frozen. Upon thawing, aliquots must be
well mixed before use. Presence of obvious turbidity after
reaction with cyanmethemoglobin reagent indicates deterioration
and product should not be used.
