Interpretation Of Results; Quality Control; Performance Characteristics - Gima 24555 Manual De Uso

NEGATIVE:* A colored line in the control line region (C) and a colored line in the test line region (T)
for a specific drug indicate a negative result. This indicates that the drug concentration in the oral fluid
specimen is below the designated cut-off level for that specific drug.
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative
whenever there is even a faint colored line.
POSITIVE: A colored line in the control line region (C) but no line in the test line region (T) for a
specific drug indicates a positive result. This indicates that the drug concentration in the oral fluid
specimen exceeds the designated cut-off for that specific drug.
INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and repeat the test
using a new test device. If the problem persists, discontinue using the lot immediately and contact your
local distributor.
A procedural control is included in the test. A colored line appearing in the control region (C) is
considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane
wicking and correct procedural technique. Control standards are not supplied with this kit; however,
it is recommended that positive and negative controls be tested as a good laboratory practice to confirm
the test procedure and to verify proper test performance. LIMITATIONS
1. The Multi-Drug One Step Multi-Line Screen Test Device (Oral Fluid) provides only a qualitative,
preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result.
Gas chromatography/mass spectrometry (GC/MS) or gas chromatography/tandem mass spectrometry
(GC/MS/MS) is the preferred confirmatory method.
2. A positive test result does not indicate the concentration of drug in the specimen or the route of
administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the
specimen below the cut-off level of the test.
A phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of ± 50% cut-
off and ± 25% cut-off and tested with the Multi-Drug One Step Multi-Line Screen Test Device (Oral
Fluid). The results are summarized below.
The following table lists the concentration of compounds (ng/mL) above which the Multi-Drug One
Step Multi-Line Screen Test Device (Oral Fluid) identified positive results at 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the previous illustration)

QUALITY CONTROL

PERFORMANCE CHARACTERISTICS

Analytical Sensitivity
Analytical Specificity
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