CE Marked Infectious Malaria/HCV/Hbsag/Syphilis/HP/HIV1+2 Antibody Rapid Test Kit

• Customization: Available
• Type: IVD Reagent
• Certification: CE, ISO13485
• Model NO.: S01-TP-25
• Warranty: 2 Years
• Transport Package: Plastic Bag, Sealed Carton
• Specification: 25T/box Customized
• Trademark: Sekbio/OEM
• Origin: Shenzhen
• HS Code: 3002150090
• Production Capacity: 1000000

Product Description

 

Product Description

 

It is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test.
 

After specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, 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.

 

Specimens	Whole Blood/Serum/Plasma	Format	Cassette/strip
Reading time	10 minutes	Pack	25 T
Storage	2‐30°C	Kit Components	Test devices/strips,Droppers,Buffer,Package insert

Directions for use

 

Allow the test, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.

• 1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
• 2.Place the device on a clean and level surface.
• For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25mL) to the specimen well (S), then add 2 drops of buffer  (approximately 80mL), and start the timer.
• For Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80mL) to the specimen well (S), then add 1 drop of buffer (approximately 40 mL), and start the timer.
• 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.

 

Result Interpretation

Negative result
Only the quality control C line appears and the detection T line does not show color, it indicates that t there is no determinand in the specimen.
Positive Result
Both the quality control C line and the detection T line appear, aThis indicates that the specimen contains detectable amount of determinand.
Invalid Result
No visible colored band appears at control line after performing the test.
Review the test procedure and repeat the test using a new test device.

NOTE:
The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

 

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