Uncut sheet for lgG/igM Antibody to Dengue

Short Description:

lgG/igM Antibody to Dengue rapid test uncut sheet

Methodology: Colloidal Gold

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

Send email to us

Product Detail

Product Tags

1. INTEDED USE

The Dengue IgG/IgM Rapid Test Device (the “uncut sheet” format for manufacturing use) is intended for the qualitative and differential detection of IgG and IgM antibodies to Dengue virus (DENV) in human serum, plasma, or whole blood specimens

This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of primary and secondary Dengue virus infections in patients presenting with clinical signs and symptoms suggestive of Dengue fever, such as sudden onset of high fever, severe headache, retro-orbital pain, myalgia, arthralgia, and rash.

The device provides presumptive screening results ,results obtained shall be used in combination with other clinical information for analysis.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.

2. PRODUCT SPECIFICATION

Model No.	Dengue lgG/lgM AntibodyUncut sheet
Methodology	Colloidal Gold
Sample Type	whole blood/Serum/Plasma
Time to Result	15~20mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485, CE Certificate, UCKA MHRA Certificate

Feature

• High sensitive

• result reading in 15-20 minutes

• Easy operation

• High Accuracy

PACKING

* 20 bags /CTN

* Aluminum foil bag labeling

* shrink wrap

3.TEST METHOD

1	Remove detection reagent and sample to be detected from storage condition and equilibrate them to room temperature.
2	Open aluminum foil pouch of reagent, take out test device, and place it horizontally on laboratory bench;
3	Use disposable pipette provided to pipette sample. lf serum or plasma sample is usedD2one can directly and vertically add 8 drops (approx 80 μL) to "D1" well without addingsample diluent and start counting time. lf whole blood sample is used, vertically add 8drops (approx 80 uL) to "D1" well, then term sample diluent upside down, discard first 2drops of sample diluent, vertically and slowly add 1 drop of bubble-free sample diluent dropwise to "D1" wel, and start counting time.
4	Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes.