ENGLISH
RSV Control Kit
INTENDED USE
Remel Xpect
®
RSV Control Kit contains a positive and negative liquid
control for use with the Remel Xpect
®
RSV test kit. The controls are
for professional use only.
SUMMARY AND EXPLANATION
The use of known controls in the laboratory is invaluable. It is
important to verify testing procedures to confirm that the results
reported are valid. Testing with Xpect
®
RSV Control Kit will provide
assurance that the Xpect
®
RSV test kit is performing properly.
PRINCIPLE
Xpect
®
RSV Control Kit is designed to assist in verifying performance
of the Xpect
®
RSV test kit. The positive control contains RSV antigen
and should produce a positive result with the test. The negative
control does not contain RSV antigen and should produce a negative
result. If the proper results are not achieved, the Xpect
®
RSV test kit
may not be working properly and results should be considered
inconclusive.
REAGENTS
1.
RSV Positive Control (1.0 ml):
Inactivated RSV antigen (Long
Strain) containing sodium azide (0.1%)
2.
RSV Negative Control (1.0 ml):
Contains sodium azide (0.1%)
3.
Instructions for Use
(IFU)
STORAGE
Store the Xpect
®
RSV Control Kit at 2-8°C until used.
PRECAUTIONS
1. For
In Vitro
Diagnostic Use.
2.
Refer to the Xpect
®
RSV test kit IFU for specific precautions
related to the test.
3. Do not use controls if they are cloudy or precipitates are
observed in the vials. This may be an indication of reagent
instability or product deterioration.
4.
The controls contain 0.1% sodium azide.
Caution!
Harmful if
swallowed. Refer to Material Safety Data Sheet for more
information.
5.
Do not use controls beyond the expiration date.
6.
Controls should be considered potentially hazardous and handled
in the same manner as an infectious agent.
MATERIALS REQUIRED BUT NOT SUPPLIED
1. Xpect
®
RSV test kit (REF R24601, 30 tests/kit)
PROCEDURE
1.
Allow controls to equilibrate to room temperature (15-30°C) prior
to testing.
2.
The controls are ready to use. No dilution or extraction is required.
3.
The controls are used in place of the specimen/extraction buffer
solution and should be tested according to the Xpect
®
RSV test
kit IFU.
NOTE:
The dropper tip of each control bottle must be removed
prior to removing sample.
INTERPRETATION
The test should produce positive and negative results with the
corresponding liquid control as outlined in the Xpect
®
RSV test kit IFU.
The test should be repeated if invalid results are obtained.
QUALITY CONTROL
Good laboratory practice recommends the use of positive and
negative controls to ensure functionality of reagents and proper
performance of the assay procedure. The Positive Control and
Negative Control are intended to monitor for substantial reagent
failure and will not monitor the antigen extraction procedure nor
ensure precision at assay cut-off. It is recommended that these
controls be tested once with each new lot number or shipment and
thereafter according to each laboratory’s applicable guidelines.
Quality control must be performed in accordance with local, state,
and/or federal regulations or accreditation requirements. Refer to
CLSI EP12-A and 42 CFR 493.1202(c) for guidance on appropriate
quality control practices. Additional controls, such as a positive
patient specimen, may be tested to monitor for antigen extraction and
stability. If aberrant quality control results are noted, patient results
should not be reported.
LIMITATIONS
These controls are formulated for use as quality control samples in
the reagent verification of Xpect
®
RSV test. See IFU 24601 for
guidelines in procedure and interpretation, and for further limitations.
PERFORMANCE CHARACTERISTICS
Xpect
®
RSV Control Kit has been designed to produce correct results
when used with the Xpect
®
RSV test kit. These controls have been
tested with the Xpect
®
RSV test kit and were found to produce
satisfactory results.
1
REFERENCES
1.
Data on file. Remel Inc.
PACKAGING
REF R246012, Xpect
®
RSV Control Kit................................ 2 Vials/Kit
Symbol Legend
REF
Catalog Number
IVD
In Vitro
Diagnostic Medical Device
LAB
For Laboratory Use
Consult Instructions for Use (IFU)
Temperature Limitation (Storage Temp.)
LOT
Batch Code (Lot Number)
Use By (Expiration Date)
EC REP
European Authorized Representative
Manufactured for Remel Inc.
Xpect
®
is a registered trademark of Remel Inc.
IFU 246012, Revised January 23, 2007
Printed in U.S.A.
12076 Santa Fe Drive, Lenexa, KS 66215, USA
General Information: (800) 255-6730 Technical Service: (800) 447-3641 Order Entry: (800) 447-3635
Local/International Phone: (913) 888-0939 International Fax: (913) 895-4128
Website: www.remel.com Email: [email protected]
