ACCURUN® 140

Rubella IgG Positive Control

0086

SeraCare Life Sciences, Inc. | 37 Birch Street, Milford, MA 01757 USA

EC REP Phone: +1 508.244.6400 | [email protected]

MEDIMARK® Europe
11, rue Émile Zola BP 2332
38033 Grenoble Cedex 2 – France
+ 33 (0) 4 76 86 43 22 10017US-13 March 2017
[email protected]

Explanation of symbols used in SeraCare product labeling

EC REP

Authorized Representative in
Upper limit of temperature Temperature limitation the European Community

IVD

Biological risks Use By In Vitro Diagnostic Medical Device

CONTROL - REF

Negative control Catalogue number Consult instructions for use

CONTROL + LOT

Positive control Batch code Manufacturer

Control Highly Flammable Toxic by inhalation, in contact

with skin and if swallowed

Health Hazard
 THESE REAGENTS MUST NOT BE SUBSTITUTED FOR THE MANDATORY POSITIVE AND
US NEGATIVE CONTROL REAGENTS PROVIDED WITH MANUFACTURED TEST KITS.

ACCURUN® 140 Rubella IgG Positive Control

NAME AND INTENDED USE Instructions for Use
ACCURUN controls are intended to estimate laboratory testing precision and can be used to detect Allow the controls to reach room temperature prior to use, then return controls to refrigerated storage
errors in laboratory testing procedures. ACCURUN® 140 Rubella IgG Positive Control is formulated for immediately after use. Mix the contents of the vials by gentle inversion. ACCURUN controls should be
use as an unassayed control with in vitro diagnostic test kits for the qualitative determination of IgG included in a test run using exactly the same procedure provided by the manufacturer for unknown
antibodies to Rubella virus. This product is not intended for use in testing blood or plasma donors. A specimens. ACCURUN controls must NOT be substituted for the positive and negative control
negative control for Rubella IgG is available separately from SeraCare Life Sciences. THESE reagents provided with manufactured test kits.
REAGENTS MUST NOT BE SUBSTITUTED FOR THE MANDATORY POSITIVE AND NEGATIVE
CONTROL REAGENTS PROVIDED WITH MANUFACTURED TEST KITS. For In Vitro Diagnostic Use. Quality Control
Since ACCURUN controls do not have assigned values, it is recommended that each laboratory
SUMMARY validate the use of each lot of ACCURUN with each specific assay system prior to its routine use in
Frequent testing of independent quality control samples provides the analyst with a means of the laboratory.
monitoring the performance of laboratory assays. Routine use of controls enables laboratories to
monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can INTERPRETATION OF RESULTS
assist in identifying increases in random or systematic error. A well designed quality control program Levels of reactivity of ACCURUN 140 Rubella IgG Positive Control may vary with different
can provide added confidence in the reliability of results obtained for unknown specimens. The use of manufacturers’ tests and different test kit lots. Since the control does not have an assigned value, the
low-reactive samples as independent controls may provide valuable information concerning laboratory laboratory must establish a range for each lot of ACCURUN 140 Rubella IgG Positive Control. When
proficiency and kit lot variation that may affect assay sensitivity 1. results for ACCURUN 140 Rubella IgG Positive Control are outside the established acceptable range
of values, it may be an indication of unsatisfactory test performance. Possible sources of discrepancy
PRINCIPLES OF THE PROCEDURE include: deterioration of test kit reagents, operator error, faulty performance of equipment, or
ACCURUN 140 Rubella IgG Positive Control is designed for use with in vitro assay procedures for contamination of reagents.
purposes of monitoring test performance. ACCURUN 140 Rubella IgG Positive Control is
manufactured from human serum or plasma reactive for anti-Rubella and nonreactive for HBsAg and LIMITATIONS OF THE PROCEDURE
antibodies to HIV 1 and 2, HTLV, and HCV. ACCURUN controls do not have assigned values. Specific ACCURUN CONTROLS MUST NOT BE SUBSTITUTED FOR THE POSITIVE AND NEGATIVE
levels of reactivity will vary among different manufacturers’ assays, different procedures, different lot CONTROL REAGENTS PROVIDED WITH MANUFACTURED TEST KITS.
numbers, and different laboratories. TEST PROCEDURES and INTERPRETATION OF RESULTS provided by manufacturers of test
kits must be followed closely. Deviations from procedures recommended by test kit manufacturers
REAGENTS may produce unreliable results. ACCURUN controls are not calibrators and should not be used for
Item No. 2015-0084 1 vial, 5.0 mL per vial assay calibration. These controls should be used when testing serum or plasma specimens.
Performance characteristics for ACCURUN 140 Rubella IgG Positive Control have been established
This control contains Rubella IgG antibody as assayed by EIA, stabilizers (EDTA and buffering only for Rubella IgG. Adverse shipping and/or storage conditions or use of outdated controls may
agents), and 0.1% ProClin® (5-chloro-2-methyl-4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) produce erroneous results.
as preservative.
EXPECTED RESULTS
WARNINGS AND PRECAUTIONS ACCURUN 140 Rubella IgG Positive Control DOES NOT HAVE AN ASSIGNED VALUE. Specific
For In Vitro Diagnostic Use levels of reactivity will vary among different manufacturers’ assays, different procedures, different lot
CAUTION: Handle ACCURUN controls and all human blood products as though capable of numbers, and different laboratories. Procedures for implementing a quality assurance program and
transmitting infectious agents. ACCURUN 140 Rubella IgG Positive Control is manufactured from monitoring test performance on a routine basis must be established by each individual laboratory.
human serum or plasma nonreactive for HBsAg and antibodies to HIV 1 and 2, HTLV, and HCV with Each laboratory should establish its own range of acceptable values for each analyte. For example,
current FDA licensed tests. the acceptable range might include all values within 2 standard deviations of the mean of 20 data
points obtained in 20 runs over a period of 30 days 3.
Safety Precautions
Use the Centers for Disease Control (CDC) recommended universal precautions for handling SPECIFIC PERFORMANCE CHARACTERISTICS
ACCURUN and human blood2. Do not pipette by mouth; do not eat or drink in areas where specimens ACCURUN controls have been designed for use with in vitro assay procedures for purposes of
are being handled. Clean any spillage by immediately wiping up with 0.5% sodium hypochlorite monitoring assay performance. ACCURUN 140 Rubella IgG Positive Control is manufactured from
solution. Dispose of all specimens, controls and materials used in testing as though they contain human serum or plasma reactive for anti-Rubella and nonreactive for HBsAg and antibodies to
infectious agents. HIV 1 and 2, HTLV, and HCV. ACCURUN controls do not have assigned values. Specific levels of
reactivity will vary among different manufacturers’ assays, different procedures, different lot numbers,
Handling Precautions and different laboratories. Procedures for implementing a quality assurance program and monitoring
Do not use ACCURUN controls beyond the expiration date. Avoid microbial contamination of the test performance on a routine basis must be established by each individual laboratory.
controls when opening and closing the vials.
REFERENCES
STORAGE INSTRUCTIONS 1. Green IV GA, Carey RN, Westgard JO, Carten T, Shablesky LA, Achord D, Page E, and Le AV.
Store ACCURUN 140 Rubella IgG Positive Control at 2-8°C. Once opened, ACCURUN 140 Rubella Quality control for qualitative assays: quantitative QC procedure designed to assure analytical
IgG Positive Control should be stored refrigerated at 2-8°C and discarded after 60 days. After opening, quality required for an ELISA for hepatitis B surface antigen. Clin. Chem. 43:9 1618–1621, 1997.
record the date opened and the expiration date on the vial. Multiple freeze-thaw cycles are not 2. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices
recommended, and may have variable adverse effects upon test results. To prevent leakage, store Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of
vials upright. Infectious Agents in Healthcare Settings.
3. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved
INDICATIONS OF REAGENT INSTABILITY OR DETERIORATION Guideline– Second Edition. NCCLS document C24-A2, 1999.
Alterations in physical appearance may indicate instability or deterioration of ACCURUN controls.
Solutions that are visibly turbid should be discarded. For assistance, contact SeraCare Technical Support at +1 508.244.6400.

PROCEDURE
Materials Provided
ACCURUN 140 Rubella IgG Positive Control is manufactured from human serum or plasma reactive
for anti-Rubella and nonreactive for HBsAg and antibodies to HIV 1 and 2, HTLV, and HCV.

Materials Required but not Provided

Refer to instructions supplied by manufacturers of the test kits to be used.

Phone: +1 508.244.6400 | Toll Free (US Only) 800.676.1881

10017US-13 March 2017
Fax: +1.508.634.3334 | SeraCare.com