Thermo Fisher Scientific AcroMetrix User Manual
AcroMetrix™ CT/NG Control
For In Vitro Diagnostic Use
Rx Only
967146 AcroMetrix CT/NG Control
Intended Use
The AcroMetrix™ CT/NG Control is intended for use in assessing the performance of nucleic
acid test procedures for the determination of the presence of CT and NG nucleic acid.
Routine use of an external run control enables laboratories to monitor day-to-day test
variation, lot-to-lot performance of test kits, and operator variation, and can assist in
identifying increases in random or systematic error. This product is for in vitro diagnostic use.
Summary and Explanation
The AcroMetrix CT/NG Control contains inactivated Chlamydia trachomatis (CT) and
inactivated Neisseria gonorrhoeae (NG) bacterial cells. The positive control was produced by
diluting quantied CT and NG stock into a proprietary matrix. The AcroMetrix CT/NG Control
is manufactured to provide a metrological traceable value and uncertainty according to ISO
Standard 17511 (In vitro diagnostic medical devices- Measurement quantities in biological
samples- Metrological traceability of values assigned to calibrators and control materials).
The AcroMetrix CT/NG Control is designed as an unassayed control for use in qualitative
molecular test procedures for the detection of CT and NG nucleic acid.
Principles of the Procedure
The AcroMetrix CT/NG Control has been formulated to mimic naturally occurring human
specimens containing CT and/or NG. Additionally, the intact bacterial format of the AcroMetrix
CT/NG Control allows for the verication of effective bacterial nucleic acid extraction and
purication. The controls are designed to monitor procedural steps in test procedures for
determining the presence of CT and NG nucleic acid. The AcroMetrix CT/NG Control contains
intact bacteria, and the test methodology must include an extraction step that releases the
bacterial nucleic acid for amplication and detection, as appropriate to the test.
The AcroMetrix CT/NG Control is designed to help ensure the quality of nucleic acid test
results and to monitor assay performance. Frequent testing of independent quality control
samples provides the analyst with a means of monitoring the performance of laboratory
assays. Routine use of these controls enables laboratories to monitor day-to-day test
variation, lot-to-lot performance of test kits, and operator variation, and can assist in
identifying increases in random or systematic errors.
Expected results utilizing the AcroMetrix CT/NG Control must be established by the end user
for their particular assay.
Storage Instructions
It is recommended that the AcroMetrix CT/NG Control be stored at -20°C or below.
Do not use these products beyond the expiration date printed on the bottle label.
To avoid contamination use standard techniques and good laboratory practices when
handling product.
Instructions for Use
Thaw the AcroMetrix CT/NG Control at room temperature, vortex briey, and aliquot contents
entirely within 4 hours into amounts desired for use. Aliquot product into polypropylene screw
cap vials (not supplied). Aliquots may be kept at 2-8°C for 25 days. Label aliquots with product
description including Lot Number and Expiration date. It is recommended to aliquot into
volumes appropriate for single use.
If aliquots are not to be used within 25 days, freeze aliquots at -20°C or below. When needed
the frozen aliquots may be thawed then stored at 2-8°C, for up to 25 days. Do not refreeze
aliquots.
Urine Specimen Protocol:
• Vortex control in liquid state thoroughly prior to use.
• Proceed with assay manufacturer’s instructions for processing of urine specimens,
using input volume specied by assay manufacturers.
Swab Specimen Protocol:
• Vortex control in liquid state thoroughly prior to use.
• Pipette 100 uL of the control into assay manufacturer’s transport tube.
• Proceed with assay manufacturer’s instructions for processing of swab specimen.
Limitations
The AcroMetrix CT/NG Control is intended for In vitro diagnostic use. The AcroMetrix
CT/NG Control is not intended for use as a substitute for the internal controls provided by in
vitro diagnostic kit manufacturers.
Reagents
Catalog Number Control Name Quantity
967146 AcroMetrix CT/NG Control 1 x 20 mL
Precautions and Warning
WARNING: Although the AcroMetrix CT/NG Control contains inactivated CT and NG, it should
be considered potentially biohazardous. Contains ≤25% Glycerol and ≤0.05% ProClin™ 300.
Observe universal precautions for prevention of transmission of infectious agents when
handling these materials.
H412 - Harmful to aquatic life with long lasting effects.
Avoid release to the environment. Dispose of contents/container to location in accordance
with local/regional/national/international regulations.
Do not pipette by mouth. Use personal protective equipment, including lab coats, gloves and
safety glasses. Do not eat, drink or smoke in areas where specimens are handled.
Disinfect liquids, materials or spills with a 0.5% sodium hypochlorite solution. Dispose of all
materials and liquids used in the procedure as if they contained pathogenic agents.
This product contains 0.05% ProClin 300 as a preservative.
1, 2, 3
References
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 immunodeciency virus and hepatitis B virus to health-care and public-safety
workers. MMWR 1989; 38(S-6): 1-36.
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