CK-MB Rapid Test Kit
1. Product Details
Test Name: The CK-MB Rapid Test Kit
Test Item: Human CK-MB
Specimen: Whole Blood/Serum/Plasma
The CK-MB Rapid Test Kit (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of CK-MB in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test.
During the test, the specimen reacts with the particle coated with anti-CK-MB antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generate a colored line. The Presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result.
To serve as a procedural control, a colored line will always appear in the region indicating that proper volume of specimen has been added and membrane wicking has occurred.
3. Materials Provided
(1) Test Devices
(3) Package Insert
4. Directions for Use
Allow test device, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
(1) Bring the pouch to room temperature before opening it. Remove the test device from its sealed pouch, and use as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
(2) Place the test device on a clean and level surface.
For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 μL) to the specimen well (S) of the test device, then start the timer. See illustration below.
For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 4 Veniuncture Whole Blood (approximately 100 μL) to the specimen well (S) of the test device, then start the timer. See illustration below.
For Fingersticks Whole Blood specimens:
a. To use a capillary tube: Fill the capillary tube and transfer approximately 100 μL of fingersticks whole blood specimen to the specimen well (S) of the test device, then start the timer. See illustration below.
b. To use hanging drops: Allow 4 hanging drops of of fingersticks whole blood specimen (approximately 100 μL) to fall into the specimen well (S) of the test device, then start the timer. See illustration below.
(3) Wait for the colored band(s) to appear. The result should to be read at 10 minutes. Do not interpret the result after 20 minutes.
Hangzhou Laihe Biotech Co., Ltd
Hangzhou Laihe Biotech Co., Ltd. (hereafter referred to as “Laihe Biotech”) is a life science company specialized in R & D, manufacturing, marketing and service in point-of-care testing, monitoring and health technology industry, is committed to provide fast, accurate and reliable health detection products and services.
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China