Hologic TLi IQ, Руководство пользователя

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TLi
IQ
System User Manual
1 – 1
Section 1 – Introduction
SECTION I – INTRODUCTION
For In Vitro Diagnostic Use Only
To be used by trained laboratory personnel
INTENDED USE
The Hologic TLi
IQ
®
System is intended to be used in conjunction with the Rapid fFN Cassette, the Rapid fFN Control Kit,
and the TLi
IQ
QCette
®
for the detection of fetal fibronectin in cervicovaginal secretions. Refer to the directional insert for
the Rapid fFN Cassette for detailed intended use information.
GENERAL DESCRIPTION
The TLi
IQ
®
Analyzer is an electronic optical reflectance device that converts a colorimetric reaction from a cassette into a
digitized format. The data are analyzed using multiple parameters, including a comparison of sample data to calibration
data. The analyzer provides one of three possible patient test results: Positive, Negative, or Invalid.
The result is positive if the signal intensity derived from the patient sample is greater than or equal to the reference
calibration value specified by the calibration code. The result is negative if the signal intensity derived from the patient
sample is less than the reference calibration value specified by the calibration code. The result is reported as invalid if
specific internal test criteria have not been met.