ALL TEST CTI-402 Cardiac Troponin I Rapid Test Cassette User Manual

: June 3, 2024
: ALL TEST

ALL TEST CTI-402 Cardiac Troponin I Rapid Test Cassette User Manual

Cardiac Troponin I Rapid Test Cassette (Whole Blood /Serum/Plasma)

Package Insert

REF CTI-402	English

A rapid test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I(cTnI) qualitatively in whole blood, serum or plasma. For professional in vitro diagnostic use only.

【INTENDED USE】

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

【 SUMMARY 】

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. 1 Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle. 2 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. 3 cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery. 4 Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction. 5

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in whole blood, serum or plasma. The minimum detection level is 0.5ng/mL.

【PRINCIPLE】

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of cardiac Troponin I(cTnI) in whole blood, serum or plasma. In this test procedure, capture reagent is immobilized in the test line region of the test. After specimen is added to the specimen area of the cassette, it reacts with anti-cTnI antibody coated colloid gold particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized capture reagent. The test format can detect cardiac Troponin I(cTnI) in specimens. If the specimen contains cardiac Troponin I(cTnI), a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain cardiac Troponin I(cTnI), a colored line will not appear in this region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains anti-cTnI antibody coated colloid gold particles and capture reagent coated on the membrane.

【PRECAUTIONS】

For professional in vitro diagnostic use Do not use after expiration date.
Do not eat, drink or smoke in the area where the specimens or kits are
Do not use test if pouch is
Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of
Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are
The used test should be discarded according to local
Humidity and temperature can adversely affect

【STORAGE AND STABILITY】

Store as packaged in the sealed pouch either at room temperature or refrigerated (2 -30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

The Caridiac Troponin I (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or
To collect Fingerstick Whole Blood specimens :
- Wash the patient’s hand with soap and warm water or clean with an alcohol Allow to dry.
- Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring
- Puncture the skin with a sterile Wipe away the first sign of blood.
- Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture
- Add the Fingerstick Whole Blood specimen to the test by using a capillary tube :
- Touch the end of the capillary tube to the blood until filled to approximately 75m Avoid air bubbles.
- Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood to the specimen area of the test
- Add the Fingerstick Whole Blood specimen to the test by using hanging drops :
- Position the patient’s finger so that the drop of blood is just above the specimen area of the test
- Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen area on the test cassette, or move the patient’s finger so that the hanging drop touches the center of the specimen Avoid touching the finger directly to the specimen area.
- Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed
- Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 For long term storage, specimens should be kept below -20°C.

Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 1 day of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic

【MATERIALS】

Materials provided

· Test Cassettes	· Droppers	· Buffer	· Package insert

**Materials required but not provided**

· Specimen collection Containers	· Centrifuge	· Timer
For fingerstick whole blood
· Lancets	· Heparinized capillary tubes and dispensing bulb

【DIRECTIONS FOR USE】

Allow the test, specimen, buffer and/or controls to reach room

temperature (15 -30°C) prior to testing.

Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as
Place the cassette on a clean and level For Serum or Plasma specimen:
- Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 m L) to the specimen area, then add 1 drops of buffer (approximately 40 m L ), and start the timer. See illustration

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 m L ) to the specimen area, then add 1 drops of buffer (approximately 40 m L ), and start the timer. See illustration

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 75 m L of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the See illustration below.
To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 mL) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the See illustration below.

Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20

【INTERPRETATION OF RESULTS】

(Please refer to the illustration above)
POSITIVE:* Two lines appear.* One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
NOTE:** The intensity of the color in the test line region (T) will vary depending on the concentration of cardiac Troponin I(cTnI) present in the specimen. Therefore, any shade of color in the test line region
(T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line 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 with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【QUALITY CONTROL】

A procedural control is included in the test. A colored line appearing in the control line 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】

The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use This test should be used for the detection of Troponin I in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in cTnI can be determined by this qualitative test.
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the qualitative level of cTnI in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction.
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 5ng/mL of cTnI in pecimens. A negative result at any time does not preclude the possibility of myocardial infarction.
As with all diagnostic tests, all results must be interpreted together with other clinical information available to the
Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the
There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 1 day may not run properly on the test cassette. Repeat the test with a serum or plasma specimen from the same patient using a new test

【EXPECTED VALUES】

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been compared with a leading commercial cTnI EIA test, demonstrating an overall accuracy of 99.1%.

【PERFORMANCE CHARACTERISTICS】

Sensitivity and Specificity

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial cTnI EIA test using clinical specimens. The results show that the sensitivity of the Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is 99.4% and the specificity is 99.0% relative to the leading EIA test.

Method	EIA	Total Result

Cardiac Troponin I Rapid

Test Cassette (Whole Blood/Serum/Plasma)

| Results| Positive| Negative
Positive| 172| 5| 177
Negative| 1| 472| 473
Total Result| 173| 477| 650

Relative sensitivity: 172/173=99.4% (95%CI: 96.8%~99.9%); Relative specificity: 472/477=99.0% (95%CI: 97.6%~99.7%);
Accuracy: (172+472)/(172+1+5+472)=99.1%(95%CI: 98.0%~99.7%). Confidence Intervals

Precision Intra-Assay

Within-run precision has been determined by using 15 replicates of five specimens: a negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive. The negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same five specimens: a negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive specimens. Three different lots of the Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by 10,000ng/mL Skeletal Troponin I, 2,000ng/mL Troponin T, 20,000ng/mL Cardiac Myosin, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti-HIV, anti-H.pylori, MONO, anti-CMV, anti-Rubella and anti-Toxoplasmosis positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to cTnI negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL Ascorbic Acid: 20mg/dL Albumin: 10,500mg/dL
Creatin: 200 mg/dL Hemoglobin 1,000 mg/dL
Bilirubin: 1,000mg/dL Oxalic Acid: 600mg/dL
Cholesterol: 800mg/dL Triglycerides: 1,600mg/dL None of the substances at the concentration tested interfered in the assay.

【BIBLIOGRAPHY】

Adams,et Biochemical markers of myocardial injury, Immunoassay Circulation 88:750-763, 1993.
Mehegan JP, Tobacman Cooperative interaction between troponin molecules bound to the cardiac thin filament. J.Biol.Chem. 266:966, 1991.
Adams, et Diagnosis of Perioperative myocardial infarction with measurements of cardiac troponin I. N.Eng.J.Med 330:670, 1994.
Hossein-Nia M, et Cardiac troponin I release in heart transplantation. Ann. Thorac. Surg. 61: 227, 1996.
Alpert JS, et al. Myocardial Infarction Redefined, Joint European Society of Cardiology American College of Cardiology: Am. Coll. Cardio., 36(3):959, 2000

Hangzhou AIITest Biotech Co., Ltd. #650, Yinhai Street
Hangzhou Economic & Technological Development Area
Hangzhou – 310018, P.R. China www.alltests.com.cn

MedNet GmbH Borkstrasse 1 O 48163 Muenster
Germany