Training Packet ThyroTest® TSH Waived Inverness Medical Point of Care Diagnostic Products Better Results Mean Better Medicine® Inverness Medical CLIA Packet
The following materials are provided to all Inverness Medical Customers. Laboratoriesperforming waived tests are expected to follow the manufacturer’s guidelines and good laboratory practice.
Included in this packet are the following:
CLIA Quality Control Information Letter for Waived Tests.
Quality Control and Patient Record Sheet.
List of Important Test Procedure Steps to eliminate sources of error.
Proficiency Test Information Package: x Introduction to PT x Tips for Successful Performance x List of Proficiency Providers
Test Procedure specifically written according to the standards of CLSI Guidelines.
Competency Assessment Forms for documentation of annual competencyevaluations.
Appendix: Material Safety Data Sheets (MSDS) to satisfy OSHA requirements.
02635.002006 Inverness Medical – BioStar Inc. All rights reserved.
Thank you for your interest in the Point of Care products from Inverness Medical. The ThyroTest® TSH has been categorized by CLIA as a waived complexity test.
Whenever possible, it is good laboratory practice to use Quality Control Material when performing waived tests to ensure that the test results are accurate. Per the ThyroTestTSH Insert, the built-in quality control features a pink line in Control Zone. This control should always be seen and shows: 1) that enough volume is added, 2) that proper flow is obtained, and 3) that the antibody is reactive. If this line is missing, the test was not run correctly or failed to function correctly. The manufacturer recommends running Controls for each new lot. However, Controls should be run with a minimum frequency, depending on number of tests run in the laboratory. Each laboratory should establish its own criteria based on the following parameters:
x Each new lot x Each newly opened kit (20 tests)x Each new shipment (even if from the same lot previously received)x Each new operator (an individual who has not run the tests for at least two
Quality control standards are available for the validation of device functionality from commercial sources.
Forms for QC documentation are available and may be provided to you by your Inverness Medical Sales Representative. If we may be of further service, please do not hesitate to call Technical Services at 800-637-3717.
Inverness Medical Technical Services Office
02635.002006 Inverness Medical – BioStar Inc. All rights reserved. Control and Patient Record roTest y Th Lot Number___________________Exp. Date__________ Inverness Medical recommends that external positive and negative controls be run minimally on each new
Record the Date, Patient’s Name, Patient Test Result, In
Reviewed By: _________________________________________
ThyroTest® TSH Test
1. If the laboratory modifies the test system instructions, the test is considered
“High Complexity” (non-waived) and subject to all applicable CLIA requirements.
2. Use only with finger stick blood drops using the pipette provided.
3. Each ThyroTest is run with two drops of fresh whole blood. Samples should be
tested immediately after collection into the pipette. If the blood appears to be clotted in the pipette, a new, fresh blood sample should be taken.
4. Wipe away the first drop of blood after sticking the finger with the lancet.
5. It may be necessary to rub the finger for an additional drop of blood to fill the
6. Do NOT move the test cassette during 10 minutes. Do not read after 12
7. A test is invalid if a pink line in the Control Zone is missing. The test should be
02635.002006 Inverness Medical - BioStar Inc. All rights reserved
This is to verify that the office staff and personnel responsible for running the ThyroTest® TSH Test at _____________________________ have been thoroughly in-serviced on the test and the test procedure. This has included:
x Review of the package insert x Demonstration of the product assay x Successful performance of the ThyroTest TSH and interpretation of results
Names of the personnel who have been trained with the ThyroTest TSH Test and are responsible for reporting patient results:
Signature of Medical Director(s) responsible for personnel and testing:
Inverness Medical Trainer: ________________
02635.002006 Inverness Medical - BioStar Inc. All rights reserved
.A Word about Proficiency Testing.
Proficiency testing (PT) is a type of external quality control. The practice of testing unknown specimens from an outside source provides an additional means to assure quality laboratory testing results. Although most labs perform quality control on samples with known values, external quality control provides important comparisons to determine the accuracy of your testing procedures.
The purpose of proficiency testing (PT) is to verify that the performance of each test site is in line with others performing the same analysis. Every four months, the PT provider sends test samples to their subscribers. The samples, whose values are unknown to the subscribers, are run by the testing personnel who return their results to the PT provider. The results are reviewed to determine whether each participant passes or fails performance levels established by federal and state agencies.
02635.002006 Inverness Medical - BioStar Inc. All rights reserved
Tips for Successful PT Performance
i Strictly follow the PT provider's storage or handling requirement before testing PT specimens.
i Analyze PT specimens within the time frame provided by the PT
i Contact the PT provider promptly when specimens are received
damaged. You may be able to receive a replacement immediately.
i Avoid clerical error when filling out PT answer sheets. Be sure to enter the correct result next to the correct analyte on the answer form.
i Remember to identify the instrument or method you are using to perform
your PT so that you are graded among your peer group.
i Make copies of all answer forms before submitting them to your PT
02635.002006 Inverness Medical - BioStar Inc. All rights reserved
Proficiency Test Providers American Association of College of American Pathologists (CAP) Bioanalysts(AAB) Surveys Program Proficiency Testing Service 325 Waukegan Road 205 West Levee Street Northfield, IL 60093-2750 Brownsville, TX 78520-5596 800-323-4040 800-234-5315 American Academy of Family College of American Pathologists (CAP) Physicians (AAFP) EXCEL Program 11400 Tomahawk Creek Pkwy 325 Waukegan Road Leawood, Ks 66211-2672 Northfield, IL 60093-2750 800-274-7911 800-323-4040 American Proficiency Institute (API) Medical Laboratory Evaluation (MLE) 1159 Business Park Drive ACP-ASIM Services Traverse City, MI 49686 2011 Pennsylvania Avenue, NW 800-333-0958 Suite 800 Washington, DC 20006-1834 800-338-2746 Accutest P.O. Box 999 Westford, MA 01886 800-356-6788
Some states provide their own in-state proficiency testing programs. Please contact your state CLIA office for more information.
02635.002006 Inverness Medical - BioStar Inc. All rights reserved
The ThyroTest one-step, rapid TSH assay for hypothyroidism screening in adults is a lateralflow chromatographic immunoassay for the qualitative determination of human thyroidstimulating hormone (TSH) in whole blood.
Thyroid stimulating hormone (TSH), or thyrotropin, is the primary regulator of the functionalstate of the thyroid gland. Its production and release is stimulated by the hypothalamic thyrotropin-releasing hormone (TRH) and is controlled by levels of the thyroid hormones(thyroxine and triodothyronine) at the pituitary gland and possibly the hypothalamus. Serum TSH levels are raised in cases of primary hypothyroidism. The diagnosis of hypothyroidism is made by finding a low total or free T4 value and is confirmed by a raised TSH level. Mild primary hypothyroidism may be more difficult to diagnose by just measuring the level of total and free T4, because the total and free T4 value can sometimes be within the normal range. In these cases, TSH assays are useful for diagnosis since the levels of TSH are raised. In hyperthyroidism, levels of T3 and T4 are raised and TSH level is reduced. II. Specimen Collection/Treatment
Acceptable: Fresh, finger stick whole bloodUnacceptable: Clotted Specimens
Acceptable: Pipette included in test pouchUnacceptable: Other containers
Samples should be tested immediately after collection into the pipette.
Patient samples, extracted samples and used test stripsshould be handled as though they are potentially infectious. III. Reagents and Equipment A. Reagents and Materials Provided
Test Cassette – 20 each – An absorbent membrane cassette individually wrappedin foil pouch, containing a plastic pipette for blood sample.
Dropper Bottle – 6 mL – Buffer Diluent.
Positive Control – 1 each 0.5mL – Positive TSH serum
Negative Control 1 each 0.5 mL – Negative TSH serum
ThyroTest TSH Controls are prepared using human serum with purified human TSH added to achieve the desired concentration levels.
CLSI ProcedurePage 1 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
B. Materials Required But Not Provided C. Storage and Stability
The test kit may be stored at room temperature (15°- 30°C; 60°- 86° F): do not freeze.
Do not use the test cassette after the date printed on the foil pouch.
Keep away from moisture, heat, or direct sunlight.
ThyroTest TSH Controls are stored at 15°-30°C (60°- 86°F) and are stable until the expiration date on the vial. After opening, the vials should be used at room temperature. The stability after opening is 30 days. D. Quality Control Internal Procedural Controls
ThyroTest contains built in control features. A pink line in the Control Zone should alwaysbe seen and shows: 1) that enough volume is added, 2) that proper flow is obtained, and 3) that the antibody is reactive. If this line is missing the test was not run correctly or failed to function correctly. A missing line in the Control Zone indicates an invalid test and shouldbe repeated using a new cassette. Quality controls standards are available for thevalidation of device functionality from commercial sources. External Quality Control Testing The manufacturer recommends that CLIA waived laboratories run Controls for each new lot. However, Controls should be run with a minimum frequency, depending on number of tests run in the laboratory. Each laboratory should establish its own criteria based on the following parameters:
Each new shipment (even if from the same lot previously received)
Each new operator (an individual who has not run the tests for at least two weeks)
Monthly, as a continued check on storage conditions
Whenever problems (storage, operator, or other) are identified
Or other times as required by your laboratory’s standard QC procedures.
The Positive and Negative controls included in the kit should be run according to laboratory requirements. These controls should be run like an unknown sample. If the controls do not give expected results (Positive or Negative), patient results must not be reported, and the test should be rerun. If external controls are preferred, it is recommended that a mid to high (Positive) and a low (Negative) control be run with a minimum frequency, dependingon number of tests run in the laboratory.
If you are not running the ThyroTest under CLIA waived status, or if your local or state regulations require more frequent testing of quality control material, quality control must be performed in compliance with those regulations. Each laboratory or testing site using the ThyroTest TSH must have a CLIA Certificate of Waiver, call your state department of health for an application form.
CLSI ProcedurePage 2 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
Remedial Actions If the test does not show any Control or Test line in the window or a smudged or partial line, the test cassette should be discarded. Do not report the results. Run the test again with a new cassette and follow the procedure exactly. If the second test does not show lines, please contact Technical Services at 800-637-3717. E. Precautions
Read instructions for use carefully before performing this test.
If the laboratory modifies the test system instructions, the test is considered “HighComplexity” (Non-waived) and subject to all applicable CLIA requirements.
Use only with finger stick blood drops using the pipette provided.
Blood specimens may be potentially infectious. Avoid contact with skin by wearinggloves and proper laboratory attire. Properly handle and discard all used test devicesin an approved biohazard container.
Do not use the buffer or cassette after the expiration date printed on the outside ofeach foil pouch.
Test buffer contains a preservative that is a poison and may be harmful if swallowed. Seek medical help if buffer is ingested.
10. The control material has been found to be non-reactive for Hepatitis-B surface antigen.
However, this product should be handled as potentially infectious. The controls contain sodium azide, which may react with lead and copper plumbing to form potentially explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up. IV. Procedure Blood Collection: Each ThyroTest is run with two drops of fresh whole blood. Samples should be tested immediately after collection into the pipette. If the blood appears to be clotted in the pipette, a new, fresh blood sample should be taken.
Rub the chosen finger towards the tip and wipe the end of the finger with an alcohol pad.
Let dry thoroughly. Alcohol will affect the test.
Stick fingertip with a lancet. Follow instructions for use.
Rub the finger towards the tip for a second drop.
Hold the pipette flat and touch end of the pipette (included in the pouch) to the dropof blood.
Let blood fill to the line on the pipette. The pipette will fill to the line by itself.
If may be necessary to rub the finger for an additional drop of blood to fill to theline. Test Procedure: 1.
Remove the test cassette and pipette from the foil pouch by tearing at slot on the side of bag. Do not remove the desiccant pack. Discard the pouch.
Place the cassette on a hard flat surface with the window facing up.
Add 2 drops of whole blood directly into Sample well on the Test Cassette with the pipette provided in the pouch. Discard the pipette after use into a waste containerwhen done.
Add six (6) drops of Test Buffer into the Sample well on the Test Cassette.
Set a timer for 10 minutes. Do NOT move the cassette during this time.
CLSI ProcedurePage 3 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
At the end of the 10 minutes, read the line(s) in the window of the cassette. Do not move the cassette until you have checked the line(s). The test can be read up to 12 minutes. IMPORTANT: Do not read after 12 minutes Interpretation of Test Results
Negative Result: One pink/purple colored line appears in the oval window near the Control mark. No colored line near the Test mark means the TSH level is negative, and below the cut-off of 5PIU/mL.
Positive Result: In addition to the pink/purple line by the Control mark, a second pink/purple colored line seen near the Test mark means the TSH level is positive, and above the cut-off of 5PIU/mL. PLEASE NOTE: In addition to the pink/purple line by the Control mark ANY PINK/PURPLE line that is seen near the Test mark of the cassette at the 10 minute time is considered a positive result. The intensity of the line does not matter.
Invalid Result: A pink/purple line should always appear near the Control mark. If there is notpink/purple line seen near the mark, the test is invalid. Do not report the result. In this case the test should be repeated with a new cassette or call Inverness Medical Technical Services at800-637-3717. Reporting Results The results of this test should be reported to a physician for individual interpretation and managing the symptoms. VI. Limitations
Running the test at temperatures below or above room temperature (15° - 30°C; 60° - 86°F) may affect the results. Make sure the buffer and cassette are at room temperaturebefore running the test.
The blood sample must be dispensed immediately after filling the pipette. If blood is clotted, collect a new sample and re-test.
TSH elevations have been reported concomitant to hyperthyroidism in patients withneoplasia of the pituitary.
As with all screening assays, results should be considered presumptive until confirmed. Results obtained from this kit should be used only as an adjunct to other diagnosticprocedures and information available to the physician.
To avoid incorrect readings, do not interpret the test results after 12 minutes.
Check the expiration date and if the test kit is expired do not use the test cassette(s).
CLSI ProcedurePage 4 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
Sensitivity and Specificity
The following table shows the agreement of the ThyroTest TSH when compared to a laboratoryreference method using serum as the biological source for detection. Reference Test ThyroTest
Sensitivity = 81.25% Specificity = 98.28%Accuracy = 95.50%% Negative Predictive Value = 97.56% % Positive Predictive Value = 78.79%
The precision of the ThyroTest was determined using replicate assays of samples from threedifferent serum pools, with kits from three different production lots. Each specimen sample wasrun through ten parallel assays. The data showed 100% precision for the duplicates of eachsample and 100% precision from different lots.
IX. Interference Data
Other hormones and commonly found substances were tested to show that these substancesdo not interfere with the ThyroTest TSH results.
CLSI ProcedurePage 5 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
Burger, H.G., Patel, Y.C. “Thyrotropin Releasing Hormone-TSH” Clinical Endocrinology andMetabolism, Vol. 6 (1077) 83-100.
Ingbar, S.H. and Woeber, K.A. The Thyroid Gland: Textbook of Endocrinology, 6th Ed. (Williams: 1981). Chapter 4, pp. 117-243.
J.G., Endocrinology, Vol. 89 (1971): 1331-1344.
Utiger, R.D., “The Thyroid,” in S.C. Werner and S.H. Ingbar, eds. (Harper 7 Row:Hagerstown, MD, 1078) pp.196-205.
Sairam, M.R. and L.I., C.H. “Human Pituitary Thyrotropin: Isolation and ChemicalCharacterization of its Subunits, “Biochemical and Biophysical Research Communications,Vol. 51 (1973): 336-342.
Shome, B. and Parlow, A. F. “Human Follicle Stimulating Hormone (hFSH): First proposalfor the amino acid sequence of the alpha subunit (hFSH alpha) and first demonstration of it’s identity with the alpha subunit of human luteinizing hormone (hLH)”, Journal of ClinicalEndocrinology and Metabolism, Vol. 3 (1974); 192-202.
Everd, D, “Disease of the Thyroid Gland”, Clinics in Endocrinology and Metabolism, Vol. 3 (1974): 425-450.
Everd, D.C. Ormston, B.J., Smith, P.A., Hall, R, and Bird, D.T. “Grades of Hypothyroidism,”British Medical Journal, Vol. 1 (1973): 657-662.
Caldwell, G., Gow, S.M., Sweeting, V.M., Rellent, H.A., Beckett G.J., Seth, J. and Toft, A.D. “ A New Strategy for Thyroid Function Testing,” Lancet, Vol. 1 (1985): 1117-1119.
10. Dussault, J.J. Ponlow, A., Letare J. Guyda, H. and Leberge, C. “TSH Measurements from
Blood Spots on Filter paper: A confirmatory Screening test for Neonatal Hypothyroidism,”Journal of Pediatrics, Vol. 89 (1976): 550-552.
ThyroTest is a registered trademark of Thyrotec, Inc.
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Test Procedure Review
CLSI ProcedurePage 7 of 7 02635.002006 Inverness Medical - BioStar Inc. All rights reserved
ThyroTest® TSH Competency Assessment …A Word about Personnel Competency Assessment …
According to the CLIA ’88 Rules and Regulations, laboratories possessing a certificate of waiver are only required to:
9Enroll in the CLIA program. 9Pay applicable certificate fees biennially. 9Perform only tests that have been classified as waived by the FDA or CDC. 9Follow manufacturers’ test instructions.
Currently, there are no personnel requirements that must be met by certificate of waiver laboratories. However, certificate of waiver laboratories are expected to follow good laboratory practices.
Good Laboratory Practice Good laboratory practices are a set of procedures that span all phases of testing (pre- analytical, analytical and post-analytical) and are employed by a laboratory for the purpose of achieving accurate and timely test results. All laboratories, regardless of complexity, are recommended to follow these practices. At a minimum laboratories are recommended to have:
1. A procedure manual that contains procedures for all tests performed in the
2. A system to train all employees and ensure their competence to perform laboratory
3. A system to ensure that patient preparation and specimen collection, identification,
handling, and storage policies and procedures are in place and adequately followed.
4. A system to ensure that all paperwork associated with a patient’s test is handled in a
manner to facilitate the timely reporting of results, including panic values, confidentiality of results, and storage of the results.
5. General policies and procedures written and followed regarding laboratory safety
including the use of Universal Precautions and the prohibition of eating, drinking, or storage of food in the laboratory.
6. A system designed to oversee the storage of kits, reagents, and controls as required
by the manufacturer and to ensure that when outdated they are properly disposed.
7. A system developed to monitor the use of, and interpret the results of, either the
manufacturer’s built-in controls or external quality control material to ensure that the test system is operating correctly.1
Competency Assessment Although not a requirement per CLIA law, evaluation of competency of testing personnel is an important part of good laboratory practice. Providing regular training, appropriate education, and evaluating and maintaining competency of testing personnel is essential to achieving accurate test results. Evaluating and documenting the performance of the individuals responsible for testing can be semi-annually during the first year the individual tests patient specimens. Thereafter, annual evaluations are sufficient unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance can be re-evaluated to include the use of the new test methodology or instrumentation.
Competency Assessment Page 1 of 5 02635.002006 Inverness Medical – BioStar Inc. All rights reserved.
The procedures for evaluating the competency of the staff can include but are not limited to:
1. Direct observations of routine patient test performance, including patient
preparation, if applicable, specimen handling, processing and testing.
2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records,
proficiency testing results, and preventive maintenance records.
4. Direct observation of performance of instrument maintenance and function
5. Assessment of test performance through testing previously analyzed specimens,
internal blind testing samples or external proficiency testing samples.
6. Assessment of problem solving skills.
In addition, evaluation of competency may also include a written quiz.
Inverness Medical Competency Assessment Tools As an Inverness Medical customer you are provided with the following to help maintain and evaluate testing personnel competence:
x The Training Certificate in the CLIA packet can be used as documentation that
appropriate training has been provided to all testing personnel for the ThyroTest TSHtest.
x We have provided you with a written quiz that can be administered to all testing
personnel as part of their competency assessment.
x A Competency Assessment Checklist has been created that can be used to verify
and document that all areas of competency for the ThyroTest TSH test have been evaluated.
1.COLA LabGuide, General Information on Waived Tests, 11-1, 4/9/97.
Attachments:Competency Assessment Answer Key Competency Assessment Personnel Checklist Competency Assessment Quiz
Competency Assessment Page 2 of 5 02635.002006 Inverness Medical – BioStar Inc. All rights reserved. ThyroTest® TSH Quiz Answer Key
The test kit may be stored at room temperature (15° – 30°C; 60° - 86F); do not freeze.
Running the test at temperatures below or above Room Temperature (15° - 30°C; 60° - 86°) may affect results. Make sure the buffer and cassette are at room temperature before running the test.
Each ThyroTest TSH is run with two drops of fresh whole blood. Samples should be tested immediately after collection into the pipette.
ThyroTest TSH Controls, when unopened, are stable until the expiration date on the vial. After opening, the vials are stable for 30 days.
The ThyroTest TSH test is a categorized as a CLIA waived test. Each laboratory or testing site using the test
The built in quality control feature (pink line in control zone) indicates: thatenough volume is added, proper flow is obtained, and the antibody is reactive.
A positive result means the TSH level is above the cut-off of 5 μIU/mL.
Timer should be set for 10 minutes. At the end of the 10 minutes, read theline(s) in the window of the cassette. Do not move the cassette until you have checked the line(s). The test can be read up to 12 minutes.
A positive result is a pink/purple line by the Control mark, and a pink/purple line seen near the Test mark.
The ThyroTest TSH test is a one step, rapid TSH assay for hypothyroidismscreening in adults and should be considered preliminary until confirmed.
Competency Assessment Page 3 of 5 02635.002006 Inverness Medical – BioStar Inc. All rights reserved. Comments/Corrective pplicable A Unsatisfactory Assessment Satisfactory Procedure Testing Personnel Competency Test Method: Thy Evaluator: ThyroTest® TSH Quiz
Circle T (True) or F (False) for each Question:
The ThyroTest® TSH test kit requires refrigeration at 2q to 8qC.
Running the test at temperatures below or above Room Temperature
(15° - 30°C; 60° - 86°) may affect results.
Either serum or whole blood may be used as acceptable sample types for
After the control vials have been opened they are stable for 30 days.
The ThyroTest TSH test is a CLIA waived test.
The built-in Quality Control feature does not indicate if the proper flow is
A positive result means the TSH level is above the cut-off of 1.5 μIU/mL.
Test Results should be read at 10 minutes.
The appearance of a pink/purple Control Line and a pink/purple Sample
The results obtained with the ThyroTest TSH test are definitive for
Competency Assessment Page 5 of 5 02635.002006 Inverness Medical – BioStar Inc. All rights reserved. ThyroTec, Inc 1801 Horseshoe Pike, Suite 1 Honey Brook, PA 19344 610-942-8971 Safety Data Sheet 1. Product – ThyroTest TSH Test Kit 2. COMPOSTION/COMPONENTS INFORMATION hazardous components1. Sodium azide in diluent
3. HAZARDS IDENTIFICATION N/A 4. FIRST AID 5. DISPOSITIONS AGAINST FIRE 6. DISPOSITIONS AFTER ACCIDENTAL SPILLING 7. HANDLING AND STORAGE 8. RECOMMENDATIONS FOR EXPOSURE/PERSONAL PROTECTION 9. PHYSICAL AND CHEMICAL PROPERTIES (LIQUID COMPONENTS ONLY) 10. STABILITY AND REACTIVITY
Hazardous products from decomposition: N/A
11. TOXICOLOGIC INFORMATION 12. ECOLOGIC INFORMATION 13. RECOMMENDATIONS FOR DISPOSAL 14. RECOMMENDATIONS FOR SHIPMENT 15. LEGAL INFORMATION
Labeling in conformance with EU directives: conforms
16. OTHER INFORMATION
This information cannot be considered as exhaustive but rather as guidelines.
Central Union High School District Health and Welfare Benefits 2010-2011 All Benefit Eligible Classified Employees (and COBRA Enrollees) Carol Moreno, Director of Human Resources HEALTH AND WELFARE BENEFITS EFFECTIVE OCTOBER 1, 2010 The annual open enrollment for making medical, dental, vision and life insurance plan changes is from Tuesday, August 10, 2010 through Friday, Se
Current management of glaucoma Kenneth Schwartza and Donald Budenzb Purpose of review Introduction This study reviews current concepts in the goals of glaucomaThe management of glaucoma typically proceeds fromtherapy, interventional sequence, and options for theinterventions that are the safest and the least invasive, tomanagement of glaucoma in light of recent clinical trials. those