Microsoft word - tca_121031h-1 _6-3-06_.doc

MATERIAL REQUIRED BUT NOT PROVIDED

STORAGE AND STABILITY
Store the kit at room temperature 15-30°C (59-86°F). Each device may be used
until the expiration date printed on the label if it remains sealed in its foil pouch
containing a desiccant.
Do not freeze and/or expose the kit to temperatures over 30°C.
SPECIMEN COLLECTION
1.
Each urine specimen must be collected in a clean container. Specimens may be kept at 15-30°C (59-86°F) for at least 8 hours, at 2-8°C for up to 3 days and at -20°C or lower for long term storage. Do not mix specimens. PRECAUTION
The instructions must be followed to obtain accurate results. Do not open the sealed pouch, unless ready to conduct the assay. OneStep TCA RapiDip IntaTest
Cat. No. 121031H-1
Dispose of all specimens and used assay materials as potentially biohazardous. ASSAY PROCEDURE
INTENDED USE
Refrigerated specimens and other test materials, including devices, must
This device is a one-step immunoassay intended to provide qualitative rapid be equilibrated to room temperature before testing.
detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1000 Open the foil pouch at the notch and remove the test device. ng/ml in human urine. It is for health care professional use only. Dip the device in the specimen for 10 seconds. Keep the specimen surface at the level indicated by the arrow sign on the device. This assay provides only a preliminary result. Clinical consideration and Remove the device from the specimen, and place it on a flat, dry surface. professional judgment must be applied to any drug of abuse test result, Read the test result between four (4) to seven (7) minutes after adding the particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. IMPORTANT: Do not read test results after seven (7) minutes.
Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation INTERPRETATION OF RESULTS

SUMMARY AND EXPLANATION OF THE TEST
Ttricyclic Antidepressants (TCA) are a group of antidepressant drugs that Positive:
contain three fused rings in their chemical structure.2 TCA can be taken orally or If only the Control line (C) appears, the test indicates a positive result. intramuscularly (IM). The progressive symptomatology of TCA includes Samples with positive results should be confirmed with a more specific
agitation, confusion, hallucinations, hypertonicity, seizures, and EKG changes. method before a positive determination is made.5
The half-life of TCA varies from a few hours to a few days. The commonly used Control (C) Line Test (T) Line Sample Pad tricyclic antidepressants are excreted with a very low percentage of unchanged drugs in the urine, less than 1%. Therefore, detecting TCA or metabolites of TCA in human urine has been used for screening the abuse of TCA.3, 4 This test is able to detect amitriptyline, desipramine, Imipramine and nortriptyline at a cut PRINCIPLE OF THE PROCEDURE
Negative:
This assay is a one-step lateral flow chromatographic immunoassay. The test If both the Control (C) line and Test (T) line appear, the test indicates a negative strip includes: 1) a burgundy colored conjugate pad containing mouse anti-TCA antibodies coupled to colloidal gold (the immunogen is a blend of amitriptyline, Note: A very faint line in the test region should be considered negative.
desipramine, imipramine and nortriptyline); and 2) nitrocellulose membrane containing a Test (T) line a Control (C) line. The Test line is coated with TCA- Control (C) Line Test (T) Line Sample Pad BSA, and the Control line is coated with goat anti-mouse IgG antibody. This test is a competitive binding immunoassay. The TCA metabolites in the urine specimen compete with the TCA-BSA, which is coated on the nitrocellulose membrane for the limited binding sites of the anti-TCA antibodies Invalid:
When an adequate amount of urine specimen is applied to the sample pad of the If no Control (C) line develops within 5 minutes, the test is invalid. In that case, device, the urine specimen migrates by capillary action through the test strip. If repeat the assay with a new test device. the level of TCA and/or TCA metabolites in the urine specimen is below the Control (C) Line Test (T) Line Sample Pad cutoff (1000 ng/ml), the Test line should appear as a visible burgundy line. If the level of TCA metabolites in the urine specimen is at or above the cutoff, no Test The Control line is coated with goat anti-mouse antibody, which should bind to the gold-antibody conjugate and form a burgundy color line regardless of the Control (C) Line Test (T) Line Sample Pad REAGENTS AND MATERIAL SUPPLIED
• 50 test devices, each sealed in a pouch with a desiccant. • 1 package insert (Instructions for Use). QUALITY CONTROL
concentration of 764 ng/ml. The discrepancies are shown in the following • Internal Quality Control
This test contains a built-in control feature, the Control (C) line. The presence of this Control line indicates that an adequate sample volume was ID Expected Conc.
used and that the reagents migrated properly. If a C line does not form, the test is considered invalid. In this case, review the whole procedure and • External Quality Control
Users should always follow the appropriate federal, state, and local The results from the four evaluation sites agreed 97.8% ((400-9)/400) with the guidelines concerning the running of external quality controls. SAMHSA6 concentration of nortriptyline and 99% with each other, indicating a high recommends that the concentration of drug(s) in positive and negative reproducibility of the Cortez Diagnostics, Inc. TCA Urine Test. controls be approximately 25% above and below the cutoff concentration of In-house evaluation
This study was conducted with three different lots. Specimens used in this LIMITATIONS
study were the same used for the outside evaluation. The devices were tested This test is for professional in vitro diagnostic use only. for five consecutive days five times each, for a total of 25 assays for each Results obtained by this device provide only a preliminary qualitative result. A more specific alternate chemical method must be used in order to The results were in 100% agreement among the replicates within each lot. No significant inter-lot or inter-day variation across the three different lots of This product is designed for testing human urine only. Adulterants such as bleach or other strong oxidizing agents may produce erroneous test results. When suspected, collect a fresh specimen and repeat 4. Cross-Reactivity
A study was conducted with the Cortez Diagnostics, Inc. TCA Urine Test to Samples in which bacterial contamination is suspected should not be used. evaluate the cross-reactivity of compounds structurally related to TCA. The These samples may interfere with the test and cause false results. following compounds, when spiked into known drug-free urine pools and then tested with the Cortez Diagnostics, Inc. TCA Urine Test, showed a positive PERFORMANCE CHARACTERISTICS
1. Cutoff
Description Concentration(ng/ml)
The cutoff concentration of the Cortez Diagnostics, Inc.TCA Urine Test is 2. Accuracy
The accuracy study was conducted by the comparison between the Cortez Diagnostics, Inc TCA Test and the GC/MS method. Eighty (80) clinical urine specimens were used in this study. Among the eighty (80) specimens, forty (40) were known drug-free specimens, and forty (40) contained different levels of TCA, Desipramine or Nortriptyline. The concentration of TCA was determined with GC/MS. Of the forty (40) specimens with TCA, ten (10) were below 75% of the cutoff (< 750 ng/ml), seven (7) out of the ten (10) were altered TCA clinical specimens diluted from original clinical specimens with known drug-free urine; ten (10) were within the range from 75% of the cutoff to the cutoff (750 ~ 1000 ng/ml); eight (8) were within the range from cutoff to 125% of the cutoff (1000 ~ 1250 ng/ml); and twelve (12) were above 4. Interference
125% of the cutoff (> 1250 ng/ml). All specimens were blind labeled. To evaluate the possible interference of structurally unrelated compounds with the Cortez Diagnostics, Inc. TCA Urine Test, the following analytes, Cortez Diagnostics, Inc.
usually found in urine and commonly prescribed therapeutic drugs, were Agreement
spiked in drug-free urine pools, as well as TCA positive (spiked with TCA Positive Negative
to the level of 1000 ng/ml) urine pools accordingly, and then tested with the Cortez Diagnostics, Inc. TCA Urine Test. No significant interference with either negative or positive results was observed at the concentrations listed Compounds tested and found not to interfere with the
test at 1.0 mg/ml concentration in urine
The results from the Cortez Diagnostics, Inc. TCA Urine Test agreed 100% with the TCA GC/MS data at levels below 75% of the cutoff (negative) and above the cutoff (positive). Two (2) discrepancies were observed on the Benzoylecgonine Phenylpropanalamine specimens with the GC/MS data between 75% of the cutoff and the cutoff.
3. Reproducibility

Off- site evaluation
This study was done off-site at three (3) Physician’s Office Laboratories (POL) and a clinical reference laboratory by personnel with diverse Biological analytes tested and found no interference
educational backgrounds and working experiences. One hundred (100) urine with the test at the concentrations listed
samples were divided into six groups, and spiked with nortriptyline at 0 ng/ml Biological Analytes
Concentration
(40 members), 764 ng/ml (10 members), 1024 ng/ml (10 members), 1224 ng/ml (10 members), 1425 ng/ml (18 members), and 1825 ng/ml (12 members). All samples were blind labeled and tested with the Cortez Diagnostics, Inc. TCA Urine Test. Same results were obtained for all samples except one with ID =12 at the four evaluation sites. A total of four hundred (400) Cortez Diagnostics, Inc. TCA Urine Test devices were evaluated, and they all yielded the expected results except nine (9) tested with samples at the Effect of Specific Gravity: Eight (8) human urine specimens with the
specific gravity ranging from 1.002 to 1.035 g/ml were collected in house.
Each was spiked with nortriptyline to three levels, 750, 1,500, and 2,000
ng/ml. All those specimens were tested with the Cortez Diagnostics, Inc.
TCA Urine Test, separately. The results indicated that the specific gravity
of urine, ranging from 1.002 to 1.035, did not affect the performance of the
Cortez Diagnostics, Inc. TCA Urine Test.

REFERENCES
1.
FDA Guidance for Labeling Urine Drugs of Abuse Screening Testing, Kshit Mohan, 7/21/87. Dorland’s Illustrated Medical Dictionary, 26th Edition, W.B. Saunders Company, Philadelphia, PA, pp89, 1981. 4Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA): Research Monograph 73, 1986. Wilson, John, Abused Drugs II, a Laboratory Pocket Guide. AACC Press., Washington, DC; 1994. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, 4th Edition. Biomedical Publ., Davis, CA; pp 35-39, 215-218, 392-395, 562-564, 1995. Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA): Research Monograph 73, 1986. Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, Fed. Register. 53 (69): 11970 (1988). ISO 13485-2003

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