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Cardiac Troponin I Rapid Test Kit (Lateral Chromatography)

Product details

Intended Use:

Cardiac Troponin I Rapid Test Kit applies colloidal gold immunochromatography to detect cardiac Troponin I (cTnI) in serum, plasma or whole blood sample qualitatively or semi-quantitatively with standard colorimetric card. This test is used as an aid in the diagnosis of myocardial injury such as Acute Myocardial Infarction, Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome.

Test Principles:

The Cardiac Troponin I Rapid Test Kit (Lateral Chromatography) is a qualitative or semi-quantitative, 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 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 and the color intensity of the test line increases in proportion to the cTnI concentration, 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.

Main Contents

Components provided are listed in the table.

Component  REF

REF

B032C-01

B032C-25

Test cassette

1 test

25 tests

Sample diluent

1 bottle

1 bottle

Dropper

1 piece

25 pcs

Standard colorimetric card

1 piece

1 piece

Certificate of Conformity

1 piece

1 piece

Operation Flow

Step 1: Sample Preparation 1. The test kit can be performed using whole blood, serum or plasma. Suggest choosing serum or plasma as the test sample. If choose whole blood as the test sample, it should be used together with blood sample diluent. 2. Test the sample on the test card immediately. If testing can not be completed immediately, the serum and plasma sample should be stored up to 7 days at 2~8℃ or stored at -20℃ for 6 months (whole blood sample should be stored up to 3 days at 2~8℃) until it can be tested. 3. Samples must be recovered to room temperature before testing. Frozen samples are required to be completely thawed and mixed thoroughly prior to testing, avoiding repeatedly freezing and thawing.

4. Avoid heating the samples, which can cause hemolysis and protein denaturation. It is recommended to avoid using severely hemolyzed sample. If a sample appears to be severely hemolyzed, another sample should be obtained and tested.

Step 2: Testing 1. Please read the manual carefully before testing, restore the sample, test card and blood sample diluent to room temperature and number the card. Suggest opening the foil bag after it recovery to room temperature and using the test card immediately. 2. Put the test card on a clean table, horizontally placed. For Serum or Plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 80 L, Pipette can be used in emergency) to the specimen well , and start the timer. See illustration below. For Whole Blood specimen: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 80 L) to the specimen well, then add 1 drop of Sample diluent (approximately 40 L), and start the timer. See illustration below. Step 3: Reading In 10~30 minutes, get the semi-quantitative result according to the standard colorimetric card by eyes. Interpreting the results

Valid: One purplish red streak appears on the control line (C). As for valid results, you can get a semi-quantitative by eyes with standard colorimetric card:

Color Intensity vs Reference Concentration

Color Intensity

Reference Concentration (ng / ml)

-

0.5

+ -

0.5~1

+

1~5

+ +

5~15

+ + +

15~30

+ + + +

30~50

+ + + +

50

Invalid: No purplish red streak appears on the control line(C).This means that some performances must be wrong or the test card has already been invalid. At this situation please read the manual carefully again, and try again with a new test cassette.If the same situation happened again, you should stop using this batch of products immediately and contact your supplier.

Order Information

Product Name

Cat. No

Size

Specimen

 Shelf Life

Trans. & Sto. Temp.

Cardiac Troponin I Rapid Test Kit (Lateral Chromatography)

B032C-01

1 test/kit

S/P/WB

24 Months

2-30℃

B032C-25

25 tests/kit