Download AcroMetrix™ HIV, HBV, HCV Training Panel

AcroMetrix™ HIV, HBV, HCV Training Panel
For Research Use Only
S2340 AcroMetrix HIV, HBV, HCV Training Panel
Product Use
The AcroMetrix™ HIV, HBV, HCV Training Panel is intended to qualify operators and for
validation of molecular diagnostic test procedures. The dilutions present in the AcroMetrix
HIV, HBV, HCV Training Panel should be considered as reference samples and not as
calibrators or internal controls of in vitro diagnostics (IVDs). This product can be used with
target amplification methods, including real-time PCR assays, and is useful for training and
instrument system validation. For Research Use Only. Not for use in diagnostic procedures.
Summary and Explanation
The AcroMetrix HIV, HBV, HCV Training Panel was designed and developed to meet the need
for a qualification and validation panel on detection of Human Immunodeficiency virus RNA,
Hepatitis B DNA and Hepatitis C RNA in donor blood samples. The panel helps ensure that
nucleic acid testing procedures are properly validated and that test results are consistent
across manufacturers, testing laboratories, operators, platforms and assay formats. The panel
consists of 10 samples with target concentrations ranging from 51 IU/mL to 2,500 IU/mL.
The stock materials used to make the AcroMetrix HIV, HBV, HCV Training Panel was calibrated
against WHO International Standards in accordance with ISO 17511.
The AcroMetrix HIV, HBV, HCV Training Panel members have been carefully formulated to
mimic naturally occurring human specimens containing Human Immunodeficiency virus RNA,
Hepatitis B DNA and Hepatitis C RNA. Therefore, the panel can be used with test procedures
designed for detecting blood borne viruses in blood donation samples by Nucleic Acid
Technologies.
The AcroMetrix HIV, HBV, HCV Training Panel members contain naturally occurring
non-inactivated HIV, HBV, and/or HCV1,2,3. Infection with HIV, HBV, or HCV may cause severe
health damage and death.
Storage Instructions
It is recommended that the AcroMetrix HIV, HBV, HCV Training Panel is stored at -20°C or lower
to ensure highest quality. Discard any unused material after the first use. Any panel members
that appear cloudy or contain precipitates after thawing should be discarded.
Instructions for Use
Since the panel members contain intact, encapsidated viral particles, the test methodology
should include an extraction step that releases the viral DNA or RNA and makes it available
for transcription, amplification and/or hybridization, as appropriate to the test.
Thaw the AcroMetrix HIV, HBV, HCV Training Panel members quickly in a water bath at
37°C, mix gently during thawing, vortex briefly and place on ice immediately after thawing.
The AcroMetrix HIV, HBV, HCV Training Panel members should be handled and tested in a
manner identical to that required for clinical specimens run in the NAT test procedure being
evaluated. Follow the manufacturers or testing laboratory instructions and recommendations
for the handling and testing of clinical specimens.
Limitations
The AcroMetrix HIV, HBV, HCV Training Panel is intended for qualifying operators and
validation of molecular diagnostic test procedures and not for diagnostic use. Panel members
may be used as external, independent standards for the assessment of the sensitivity of these
assays as well as Research Use Only (RUO), Analyte Specific Reagent (ASR) or homebrew.
This product is for Research Use Only. Not for use in diagnostic procedures.
Legend of Labeling Symbols
Batch Code
Use-by date
Panel Reagents
The AcroMetrix HIV, HBV, HCV Training Panel consists of 10 Panel members containing the
following target concentrations:
Panel Member
Marker
Concentration (IU/mL)*
Quantity per Vial
1
HIV-RNA genotype B
2500
1 mL
Manufacturer
Temperature Limitation
2
HCV-RNA genotype 1
99
1 mL
3
Negative
0
1 mL
4
HBV-DNA genotype A
1,351
1 mL
Catalog Number
5
HIV-RNA genotype B
250
1 mL
Research Use Only
6
Negative
0
1 mL
7
HCV-RNA genotype 1
1,000
1 mL
8
HIV-RNA genotype B
HCV-RNA genotype 1
HBV-DNA genotype A
375
99
51
1 mL
9
Negative
0
1 mL
10
HBV-DNA genotype A
135
1 mL
Biological Risk
Caution
References
* The specified values are manufacturing target concentrations. Actual quantification values
may vary from these target levels based upon the assay used to test the panel members, and
the standards used to calibrate that specific assay.
The AcroMetrix HIV, HBV, HCV Training Panel members were prepared by making dilutions of
the different NAT standards into normal human plasma (NHP). The NHP was tested negative
for HBV-DNA, HCV-RNA, HIV-1-RNA, antibodies to HCV, CMV-DNA, , antibodies to HIV-1 and
HIV-2, HBsAg, and antibodies to HTLV I-II.
Precautions and Warning
Although the NHP used in the production of this panel was determined to be negative for HBVDNA, HCV-RNA, HIV-1-RNA, antibodies to HCV, CMV-DNA, , antibodies to HIV-1 and HIV-2,
HBsAg, and antibodies to HTLV I-II, all panel members should be handled as if capable of
transmitting infectious agents.1, 2, 3.
Do not pipette by mouth. Use personal protective equipment, including lab coats, gloves and
safety glasses.
1. Centers for Disease Control (CDC). Recommendations for prevention of HIV transmission
in health care settings. MMWR 1987; 36 (supplement no. 2S).
2. Centers for Disease Control (CDC). Update: Universal precautions for prevention of
transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne
pathogens in health-care settings. MMWR 1988; 37:377-388.
3. Centers for Disease Control (CDC). Guidelines for prevention of transmission of human
immunodeficiency virus and hepatitis B virus to health-care and public-safety workers.
MMWR 1989; 38(S-6): 1-36.
Microgenics Corporation
46500 Kato Road
Fremont, CA 94538 USA
US Customer and
Technical Support:
1-800-232-3342
For insert updates go to:
www.thermoscientific.com/qualitycontrols
© 2015 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the
property of Thermo Fisher Scientific or its affiliates.
Do not eat, drink or smoke in areas where panels and specimens are handled.
Disinfect liquids, materials or spills with a 0.5% sodium hypochlorite solution or equivalent.
Dispose of all materials and liquids used in the procedure as if they contained pathogenic
agents.
MAN0004366-5
2015 01