INTENDED USE:
The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
PRODUCT SUMMARY AND EXPLANATION:
NATtrol™ Influenza A/B Positive Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable*.
Each NATtrol™ Influenza A/B Positive Control contains 6 x 0.5 mL
vials of NATtrolTM Influenza A and NATtrolTM Influenza B formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
*Pat.: http://www.zeptometrix.com/patent-information/
PRINCIPLE:
NATtrol™ Influenza A/B Positive Control contains Influenza particles inactivated by ZeptoMetrix’s patented NATtrol™ process formulated in a proprietary Purified Protein Matrix that mimics the composition of a true clinical specimen. These are full process controls designed to monitor the effectiveness of extraction, amplification, and detection in nucleic acid testing procedures. These controls are suitable for use in in-house molecular assays and commercially available platforms.
PRECAUTIONS:
Although the NATtrol™ Influenza A/B Positive Control contains inactivated microorganisms, handling and disposal should be conducted as if potentially infectious.
This control contains material of human and animal origin and the user should observe Universal Precautions when handling and disposing of this product. Disposal must follow local regulations if more stringent then regulations enforced by the CDC or the FDA.
Do not pipette by mouth.
To avoid cross-contamination, use separate transfer pipettes or tips for all materials.
Do not use beyond the expiration date shown on the label.
If product is received damaged or leaking, contact ZeptoMetrix LLC for instructions.
NOT FOR USE IN HUMANS:
These products are NOT intended for use in the manufacture or processing
of injectable products subject to licensure under the USA Food and Drug Administration Section 351 of the Public Health Service Act or for any other product intended for administration to humans.
RECOMMENDED STORAGE:
NATtrol™ Influenza A/B Positive Control should be stored at 2-8°C.
When stored as directed, controls are suitable for use for up to 35 days (5 weeks) once opened.
INSTRUCTIONS FOR USE:
Vortex NATtrol™ Influenza A/B Positive Control vials for 10 seconds to mix.
Follow the manufacturer instructions for use as a clinical sample.
LIMITATIONS:
NATtrol™ Influenza A/B Positive Control is a USA FDA Class 1 exempt, unassayed, in vitro diagnostic external run control and is for professional use only. NATtrol™ Influenza A/B Positive Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal and accreditation requirements.
EXPECTED RESULTS:
NATtrol™ Influenza A/B Positive Control tested positive for Influenza A and Influenza B in the Xpert® Xpress Flu/RSV Assay.
Product homogeneity has been demonstrated by validation studies and quality control testing.
Each laboratory must evaluate the controls and establish their own acceptance criteria.