Microsoft word - tca_121025-1 _6-16-2009_.doc

CORTEZ DIAGNOSTICS, INC.
23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 USA Tricyclic Antidepressants
RapiCard™ InstaTest
Cat # 121025-1
FOR THE QUALITATIVE ASSESSMENT OF NORTRIPTYLINE For in vitro Diagnostic and Forensic Use
INTENDED USE
The Cortez Diagnostics, Inc TCA RapiCard™ InstaTest is an immunochromatography based one step in
vitro test. It is designed for qualitative determination of Nortriptyline in human urine specimens above a cut-
off level of 1000 ng/ml. This assay may be used in the point of care setting.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method
must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry
(GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental
Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be
applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

SUMMARY AND EXPLANATION
Tricyclic Antidepressants (TCA) are a group of antidepressant drugs that contain tricyclic structure, TCA
are commonly used for the treatment of depressive disorders, it can be taken by oral or injection, TCAs are
metabolized in the liver, both TCAs and their metabolites are excreted in urine for up to 10 days. Therefore, Cortez TCA is able to detect TCAs and their metabolites, such as nortriptyline, etc. TEST PRINCIPLE
The Cortez Diagnostics, Inc. TCA RapiCard™ InstaTest is based on the principle of specific
immunochemical reaction between antibodies and antigens to analyze particular compounds in human
urine specimen. The assay relies on the competition for binding antibody between drug conjugate and free
drug which may be present in the urine specimen being tested. When drug is present in the urine
specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the
amount of drug is equal or more than the cut-off, 1000 ng/ml, it will prevent the binding of drug conjugate to
the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone,
indicating a positive result, while the presence of a colored band indicates a negative result.
A control line is present in the test window to work as procedural control. This colored band should always
appear on the control line zone if the test device is stored in good condition and the test is performed
appropriately.

MATERIALS PROVIDED
1. Instructions for use.
2. Cortez TCA test device. The amount of each coated antigen and/or antibody on the strip is less than
1.0 mg for antigen conjugate and is less than 1.0 mg for goat anti-mouse IgG antibody.
Test zone: contains TCA bovine protein antigen conjugates. Control zone: contains Goat anti-mouse IgG antibody. 3. Conjugate pad: contains mice monoclonal anti-TCA antibody.

MATERIALS REQUIRED BUT NOT PROVIDED
1. Urine collection container.
2. Timer or clock.
STORAGE AND STABILITY
The test device should be stored at 2 to 30oC and will be effective until the expiration date stated on the
package. The product is humidity-sensitive and should be used immediately after being open. Any
improperly sealed product should be discarded.
PRECAUTIONS
1. For in vitro diagnostic and forensic use only.
2. Do not use the product beyond the expiration date.
3. Handle all specimens as potentially infectious.
4. Humidity sensitive product, do not open foil pouch until it is ready to be tested.
5. Use a new urine specimen cup for each sample to avoid cross contamination.

SPECIMEN COLLECTION AND PREPARATION
It is required that approximately 150 µl of sample for each test. Fresh urine specimens do not need any
special handling or treatment. Specimens should be collected in a clean, dry, plastic or glass container. If
the assay is not performed immediately, urine specimen may be refrigerated at 2-8oC or frozen up to 7
days. Specimens should be thawed and brought to room temperature before testing. Urine specimens
exhibiting a large amount of precipitate or turbidity should be centrifuged or allowed to settle before testing.
Avoid contact with skin by wearing gloves and proper laboratory attire.
QUALITY CONTROL
Good Laboratory Practice recommends the daily use of control materials to validate the reliability of device.
Control materials should be assayed as clinical specimen and challenging to the assay cutoff
concentration, e.g., 25% above and below cutoff concentration. If control values do not fall within establish
range, assay results are invalid. Control materials which are not provided with this test kit are commercially
available.
The Cortez Drugs of Abuse Test provides a built-in process control with a different antigen/antibody
reaction at the control region (C). This control line should always appear regardless the presence of drug or
metabolite. If the control line does not appear, the test device should be discarded and the obtained result
is invalid. The presence of this control band in the control region serve as 1) verification that sufficient
volume is added, 2) that proper flow is obtained.

PROCEDURE
1. Bring all materials and specimens to room temperature.
2. Remove the test strip from the sealed foil pouch.
3. Place the transfer pipette in the specimen and depress the bulb to withdraw a sample.
4. Hold the pipette in a vertical position over the sample well of the card and deliver 3 drops(120-150ul) of
sample into the sample well.
5. Read the results at 5 minutes after adding the sample.
Do not interpret the result after 5 minutes.

INTERPRETATION OF RESULTS
Negative:
Two colored bands form. The appearance of two colored bands, one in test line zone and the other in
control line zone, indicates negative results. The negative result indicates that the nortriptyline
concentration in the specimen is either zero or less than cut-off level.
Positive:
One colored band forms. One colored band appears in control line zone. No colored band is found in test
line zone. This is an indication that the nortriptyline level in the specimen is above the cut-off level.
Invalid:
If there is no colored band in control line zone, the test result is invalid. Retest the sample with a new
device.

Note: A borderline (+/-) in test line zone should be considered negative result.

LIMITATION OF PROCEDURE
The assay is designed for use with human urine only. A positive result with any of the tests indicates only
the presence of a drug/metabolite and does not indicate or measure intoxication.
There is a possibility that technical or procedural error as well other substances in certain foods and
medicines may interfere with the test and cause false results. Please refer “SPECIFICITY” section for lists
of substances that will produce either positive results, or that do not interfere with test performance. If a
drug/metabolite is found present in the urine specimen, the assay does not indicate frequency of drug use
or distinguish between drug of abuse and certain foods and medicines.

EXPECTED RESULTS
The Cortez Diagnostics, Inc. TCA RapiCard™ InstaTest is a qualitative assay. It identifies nortriptyline in
human urine at a concentration of 1000 ng/ml or higher. The concentration of the nortriptyline cannot be
determined by this assay. The test is intended to distinguish negative result from presumptive positive
result. All positive results must be confirmed using an alternate method, preferably GC/MS.
PERRFOMANCE CHARACTERISTICS
A. Accuracy
The accuracy of the Cortez TCA test was evaluated in comparison to GC/MS at a cut-off of 1000 ng/ml of
nortriptyline. 100 urine specimens with GC/MS confirmed nortriptyline concentration were evaluated in this
study. The results are summarized and presented below:
Near cutoff
Near cutoff
Negative
negative
positive
Positive
agreement
(Less than
(between –
(between c/o
(greater
with GC/MS
–25% cut
than +25%
Positive % agreement: 97.8, Negative % agreement: 94.5. Four specimens were found discrepant between the Cortez TCA and GC/MS method. When compared those data, 75% (3 out of 4) of the discrepancy specimens were found between –25% and +25% cut-off concentration (750 – 1250 ng/ml). B. Sensitivity
The cut-off concentration (sensitivity level) of Cortez TCA test is determined to be 1000ng/ml.
C. Precision
The precision study was performed by three individuals observing the test result to determine the random
error of visual interpretation. The test results were found to have no significant differences between the
three observers.
Control Con.
No. of Tested
No. of positive
No. of borderline #
No. of negative

D. Specificity
The specificity for Cortez TCA testy was tested by adding various drugs, drug metabolites, and other
compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human
urine.
1. Interference testing
The Cortez TCA test performance at cut-off level is not affected when pH and Specific Gravity ranges of
urine specimen are at 4.0 to 9.0 and 1.005 to 1.035.
The following substances were tested and confirmed not to interfere with Cortez TCA test at the listed concentrations. Glucose 2. Specificity
The following table lists compounds that are detected by Cortez PCP test which produced positive results
when tested at levels equal or greater than the concentrations listed below:
Compounds
Con. (ng/ml)
Each listed substance that commonly found in the urine was evaluated and indicated negative result at concentration of 100 µg/ml. Acetaminophen 4-Acetamidophenol Acetylsalicylic acid Gentisic Guaiacol glycer ester Histamine 11-nor-∆8 –THC-9-COOH ( 10 µg/ml)Thioridazine Trifluoperazine Tyramine Perphenazine Chlopromazine Clomipramine REFERENCES
1. FDA Guidance for Labeling Urine Drugs of Abuse Screening Testing, Kshit Mohan,7/21/87.
2. Steven B. Karch, Drugs of abuse hand book, CRC Press, 1st. Ed. (1998)
3. Ray H. Liu and Bruce A. Goldberger, Handbook of workplace drug testing, AACC Press, Washington DC (1995) 4. Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA): Research Monograph 73,1986. Date Adopted
Reference No.
2004-11-19
DA-Tricyclic Antidepressants (TCA)-2009
CORTEZ DIAGNOSTICS, INC.
23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 ISO 9001-2009

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