Quality approved by SD BIOSENSOR / For In vitro diagnostic use only The control line appears on the membrane of the

The control line appears on the membrane of the test device after use.
Before Use After Use

CAUTION

TSH-II

TSH-II
STANDARD F

TSH-II FIA F-TSH-02

• Do not write on the bar code or damage the bar code of the test device.
• If the color of moisture indicators are changed from yellow to green, please do not use the test device.
STANDARD™ F TSH-II FIA CAUTION

PLEASE READ INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST

[Analysis of sample]
• Using a ‘STANDARD TEST’ mode
-- STANDARD F100, F200 and F2400 analyzer
1. Prepare a STANDARD F Analyzer and select the ‘Standard Test’ mode according to the analyzer’s manual. In case of
STANDARD F2400 analyzer, go to the ‘Workplace’ in the main screen. And select the ‘Run Test’
2. In case of STANDARD F200 and F2400 analyzer, input patient ID and/or operator ID on the analyzer.
EXPLANATION AND SUMMARY 3. Take the test device out of the foil pouch.
[Introduction]
Thyroid-stimulating hormone (TSH) is the hormone secreted by pituitary gland and its role is to stimulate the thyroid
4. Insert the test device to the test slot of the analyzer.
gland so that accelerates secretion of thyroid hormones like triiodothyronine (T3) and thyroxine (T4). Thyroid hormones,
When inserting the test device to the analyzer, the
T3 and T4, are made from macromolecular protein called thyroglobulin by the iodated polypeptide are separated and
analyzer will read the barcode data, and check the test
play an important part of metabolism such as regulation of body temperature and inducing energy. Decreasing level
device is valid. Select the sample type on the sample
of thyroid hormones induces TSH secretion and increasing level of thyroid hormones reduces TSH secretion according
selection screen.
to the negative feedback mechanisms. Observation of these changes of TSH level reflects the thyroid function more
sensitive than measurement of the level of thyroid hormones. Therefore, we conduct the quantitative TSH test to
see the thyroid function and predict the hypothyroidism or hyperthyroidism for each occurrence of change of TSH
level. Even though the TSH test is useful examination for identifying the thyroid function, other complete medical
examination is needed since the TSH level can be changed on other diseases as well.

[Intended use]
STANDARD F TSH-II FIA is an in vitro diagnostic use to measures the TSH in human serum and Whole blood (EDTA). The 5. Collect 35 μl of sample with a STANDARD Ezi tube+ (35
quantity measurement of the TSH is useful in the diagnosis of hypothyroidism or hyperthyroidism. This test is only for a μl).
professional use and initial screening test.

[Test principle]
STANDARD F TSH-II FIA is based on the immunofluorescence technology with STANDARD F Analyzer manufactured STANDARD Ezi tube+ (35 μl) 35µl
by SD BIOSENSOR to measure the TSH concentration in human sample. After applying the sample mixture to the test
device, the complex will be formed on the membrane as the result of the antigen-antibody reaction. The intensity of the
fluorescence light is scanned and converted into an electric signal which is proportional to the intensity of fluorescence
light produced on the membrane. STANDARD F Analyzers can analyze the TSH concentration of the clinical specimen
based on pre-programmed algorithms and display the test result on the screen.

[Kit contents]
① Test device ② Disposable dropper (100 μl) ③ STANDARDTM Ezi tube+ (35 μl) ④ Extraction buffer (100μl/vial) 6. Dispense collected sample into the extraction buffer.
⑤ Instructions for Use Then, discard the used STANDARD Ezi tube+ (35 μl).

[Materials required but not provided]

• STANDARD F Analyzer al Wa
ste
Medic

KIT STORAGE AND STABILITY

Store the kit at 2-30°C / 36-86°F, out of direct sunlight. Kit materials are stable until expiration date printed on the outer box. Put in
Do not freeze the kit.

WARNINGS AND PRECAUTIONS 7. Mix sample and buffer 2-3 times with the disposable
1. STANDARD F TSH-II FIA is for in vitro diagnostics use only.
2. Carefully follow the instructions and procedures described in this instructions before testing. dropper (100 µl). Then, collect 100 ul of the sample
3. STANDARD F TSH-II FIA should be used with STANDARD F Analyzer. mixture from the tip- end to the black line of Disposable
4. STANDARD F TSH-II FIA should remain in its original sealed pouch until ready to use. Do not use the if the pouch is dropper.
damaged or the seal is broken.
5. STANDARD F TSH-II FIA is single use only. Do not re-use it. Disposable dropper (100 μl)

6. Do not use hemolyzed samples or frozen samples. Collect

100µl
7. Do not use any artificial materials.
8. Place the analyzer on a flat surface when in use. Mix 2-3 times
9. Wash your hands in warm, soapy water. Rinse well and dry completely before testing.
10. Discard the used test kit according to the proper method.
11. Silica gel in foil pouch is to absorb moisture and keep humidity from affecting products. If the moisture indicating silica
gel beads change from yellow to green, the test device in the pouch should be discarded.
12. Collect sample mixture from the tip-end to the black line of Disposable dropper to extract 100 μl exactly. 8. Apply 4 drops of mixed sample to the sample well in the
13. Check the expiration date printed at the pouch or package. test device.
14. Use the STANDARD F TSH-II FIA at 15-32°C / 59-90°F.
15. All kit components are must be at room temperature 30 minutes before running the assay.
16. Do not write on the bar code or damage the bar code of the test device.

SPECIMEN COLLECTION AND PREPARATION 100µl

[Serum]
1. Collect the whole blood into the commercially available plain tube, NOT containing anti-coagulants such as heparin, EDTA
or sodium citrate by venipuncture and leave to settle for 30 minutes for blood coagulation and then centrifuge blood to
get serum specimen of supernatant.
2. Serum specimen may be stored at room temperature for up to 8 hours or at 2-8°C/36-46°F for up to 3 days prior to testing. 9. After applying the sample, immediately press the ‘TEST
3. For over 3 days storage, specimens may be frozen under -20ºC/-4ºF for up to 1 month.
START’ button.
4. It should be brought to room temperature prior to use.
START Test Start

[Whole blood]
• Venous whole blood
1. Collect the venous whole blood into the commercially available EDTA tube by venipuncture. <F100> <F200> <F2400>
2. Venous whole blood in a EDTA anti-coagulant tube stored at room temperature must be used in 3 hours after blood
collection for a reliable test result.
3. Venous whole blood in a EDTA anti-coagulant tube stored in a refrigerator at 1-4ºC / 34-39ºF may be used in 7 hours for a
reliable test result.
10. The analyzer will automatically display the test result
4. Do not use frozen whole blood.
5. Do not use hemolyzed blood sample. within 15 minutes.

TEST PROCEDURE
15 Incubate
15mins
[Preparation]
1. Allow kit components and collected sample to room
temperature (15-30°C/59-86°F) at least 30 minutes before
staring the test.
2. Carefully read instructions for the STANDARD F TSH-II FIA. STANDARD F TSH-II FIA • Do not put bubbles in the sample well of the test device.
3. Check the expiry date at the back of the foil pouch. Use F-TSH-02
xxxxxxxxxxxx • Discard the used test kit in proper container, according to your healthcare professional’s recommendation.
another lot if expiry date has passed.
xxxx.xx.xx

• If you feel the test result is inaccurate or do not agree your test result, do not change the treatment and
xxxx.xx.xx

CAUTION contact your healthcare professional.

INTERPRET THE TEST RESULT

4. Open the foil pouch, and check the test device and the
silica gel pack inside the foil pouch. • Results should be considered in conjunction with the clinical history and other data available to the physician.
TSH-II
• If an error message appears on the analyzer’s screen, refer to the analyzer’s manual.
Test Device

CAUTION
(36°F)
2°C
(86°F)
30°C

1. Result window Yellow

Green
Measuring range 0.1-100 mIU/L
2. Sample well
Yellow : Valid If below 0.1mIU/L , ‘0.1↓’ message will be displayed.
Green : Invalid Out of measuring range
<Foil pouch> <Device> <Silica gel>
If above 100mIU/L, ‘100↑’ message will be displayed
STANDARD™ F TSH-II FIA

0.45 to 4.5 mIU/L

TSH Reference range - Level below 0.45 mIU/L indicative of hyperthyroidism
- Level above 4.5 mIU/L indicative of hypothyroidism BIBLIOGRAPHY
1. Anderson et. al., “Narrow Individual Variations in the Serum T4 and T3 in Normal Subjects: A Clue to the Understanding
It is important for thyroid patients to know that research has shown of Subclinical Thyroid Disease,” Journal of Clinical Endocrinology and Metabolism, 87(3): 1068-1072.
that: 2. Garber J, Cobin R, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: Cosponsored by the American
-- In an iodine-sufficient population, the mean TSH is 1.5 mIU/L association of clinical endocrinologists and the American thyroid association. Endocrine Practice. 2012;18(6):988–1028.
-- In studies of population groups with a low incidence of Hashimoto's doi:10.4158/ep12280.gl.
thyroiditis, the mean TSH is 1.18 mIU/L 3. Guber HA, Farag AF. Evaluation of endocrine function. In: McPherson RA, Pincus MR, eds. Henry’s Clinical Diagnosis and
-- When people with positive antithyroid antibodies or a family history Management by Laboratory Methods. 22nd ed. Philadelphia, PA: Elsevier Saunders; 2011:chap 24.
of autoimmune thyroid disease are excluded from the reference 4. Surks, et.al. “Controversy in Clinical Endocrinology: The Thyrotropin Reference Range Should Remain Unchanged,”
range calculations, the normal reference range runs from around Journal of Clinical Endocrinology and Metabolism 90(9)/5489-5496.
Other reference value 0.4 to 2.5 mIU/L 5. Wartofsky & Dickey, “Controversy in Clinical Endocrinology: The Evidence for a Narrower Thyrotropin Reference Range
-- During pregnancy, guidelines state that TSH levels should never rise is Compelling,” Journal of Clinical Endocrinology and Metabolism
above 3.0, in order to protect the health of both mother and baby.
-- TSH levels in the higher end of the reference range are also linked
to increased risks of thyroid cancer, elevated cholesterol, infertility, Product Disclaimer
heart disease, type 2 diabetes, and a number of other health issues. Whilst every precaution has been taken to ensure the diagnostic ability and accuracy of this product, the product is used outside
-- TSH levels tend to be higher earlier in the day. A TSH test done later of the control of the SD BIOSENSOR and distributor and the result may accordingly be affected by environmental factors and/or
in the day could show your levels as within the reference range, user error. A person who is the subject of the diagnosis should consult a doctor for further confirmation of the result.
while an earlier morning test might show hypothyroidism.
Warning
The SD BIOSENSOR and distributors of this product shall not be liable for any losses, liability, claims, costs or damages whether
direct or indirect of consequential arising out of or related to an incorrect diagnosis, whether positive or negative, in the use of
The TSH reference ranges are provided for orientational purpose only. Clinicians should use the test results this product.
in conjunction with the patient’s other diagnostic findings and clinical signs, and interpret the concrete
values in the context of the patient’s clinical situation.
NOTE

CONTROL
[STANDARD F Analyzers Calibration Check]
The calibration set test of STANDARD F Analyzers should be conducted according to the analyzers’ manual.
• When to use calibration set
1. Before using the analyzer for the first time
2. When you drop the analyzer
3. Whenever you do not agree with your result
4. When you want to check the performance of an analyzer and test device
• How to use calibration set
Calibration set test is a required function that ensures optimal performance by checking the internal analyzer optics and
functions.
1. Select the ‘Calibration’ menu.
2. The specific calibration set is included with the analyzer.
3. Insert the CAL-1 first, and then insert the CAL-2 for UV-LED testing and the CAL-3 for RGB-LED testing in order.
- The STANDARD F analyzer automatically calibrate and identify the optical performance through measuring the
membrane of the test device whenever the test is conducted in ‘Standard Test’ mode. If ‘EEE’ message displays on
the screen, it means that the analyzer has a problem, so check with test device. Contact the SD BIOSENSOR local
distributor if the ‘EEE’ message still appears.

[External quality control]

Quality control testing should be run to check the performance of STANDARD F TSH-II FIA and STANDARD F Analyzers.
STANDARD™ F TSH-II Control manufactured by SD BIOSENSOR should be used for quality control testing. Control test
should be conducted in accordance with the instructions of STANDARD™ F TSH-II Control.
Control test should be run:
-- once for each new lot.
-- once for each untrained operator.
-- as required by test procedures in instructions for use of STANDARD™ F TSH-II Control and in accordance with local, state
and federal regulations or accreditation requirements.

PERFORMANCE CHARACTERISTICS
[Precision]
For precision evaluation, the within-run using the 3 levels and the Day-to-Day using the 3 levels for 20 days were done at 3 sites.
All test results were satisfied with the acceptance criteria within 15% (CV)
1. Within Run
Serum
Level 1 Level 2 Level 3
Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3
AVG. 3.83 3.80 3.70 42.59 41.16 40.30 62.80 62.07 60.23
CV (%) 12.4 11.4 10.9 13.2 11.5 11.2 12.3 10.7 10.1

Whole blood (EDTA)

Level 1 Level 2 Level 3
Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3
AVG. 2.34 2.38 2.29 5.90 5.61 5.80 55.50 56.23 54.10
CV (%) 13.2 10.2 12.8 13.6 11.8 10.0 11.8 11.5 10.8

2. Day-to-Day Study
Serum
Level 1 Level 2 Level 3
Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3
AVG. 0.54 0.54 0.54 18.60 18.85 18.29 59.88 60.86 59.92
CV (%) 10.4 9.6 10.0 10.4 8.9 9.3 9.4 7.9 8.7

Whole blood (EDTA)

Level 1 Level 2 Level 3
Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3
AVG. 3.68 3.67 3.69 6.09 6.01 6.00 75.54 75.17 75.47
CV (%) 9.2 8.4 9.1 8.9 8.1 9.1 8.9 9.0 8.5

[Accuracy (Method comparison)]

Results comparing the STANDARD F TSH-II FIA with an automated immunoturbidimetric method are presented at the below;
Regression Analysis
Slope 0.9874
Y-intercept 0.3391
R 0.9993
R2 0.9986

Acceptable system accuracy

Below -1.96SD 1 / 60 (1.7%)
Within ±1.96SD 58 / 60 (96.7%)
Over +1.96SD 1 / 60 (1.7%)

[Interfering Substances] Manufactured by SD Biosensor, Inc.

The following materials with up to the indicated concentration do not interfere with the test result. Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
REPUBLIC OF KOREA
Substance Concentration
Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-
Acetaminophen < 30 mg/dL do, 28161, REPUBLIC OF KOREA
Diltiazem < 30 mg/dL Authorized Representative
Erythromycin < 160mg/dL
Verapamil < 8 mg/dL Altenhofstrasse 80 66386 St. Ingbert Germany
Phone : +49 6894 581020, Fax : +49 6894 581021
Hemoglobin < 400mg/dL
Bilirubin < 200mg/dL Any inquiries regarding instructions provided should be addressed to: sales@sdbiosensor.com
or you can also contact us through www.sdbiosensor.com
Triglyceride < 3000mg/dL
Protein < 12g/dL L28TSH2ENR0
Issue date : 2019.05

To indicate the temperature limita�ons in Fulfill the requirements of

which the transport package has to be Direc�ve 98/79/EC on in vitro diagnos�c
kept and handled. medical devices
Reference number In vitro Diagnos�cs Consult Instruc�ons for Use Contains Sufficient Cau�on Note Do not re-use. Use by Batch code Manufacturer Date of manufacture
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