Infection Disease Dengue iggigm Antibody Rapid Test with CE
certificate uncut sheet
| Product Name | Dengue IggIgm Antibody Rapid Test uncut sheet |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the
simultaneous detection and differentiation of IgG anti–dengue virus
and IgM anti-dengue virus in human whole blood, serum or plasma. It
is intended to be used by the professionals as a screening test and
as an aid in the diagnosis of infection with dengue viruses. Any
reactive specimen with the Dengue IgG/IgM Rapid Test must be
confirmed with alternative testing method(s).
PRINCIPLE
The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is
a qualitative membrane-based immunoassay for the detection of
Dengue antibodies in whole blood, serum, or plasma. This test
consists of two components, an IgG component and an IgM component.
In the IgG component, anti-human IgG is coated in test line region
1 of the test. During testing, the specimen reacts with Dengue
antigen-coated particles in the test strip. The mixture then
migrates upward on the membrane chromatographically by capillary
action and reacts with the anti-human IgG in test line region 1. If
the specimen contains IgG antibodies to Dengue, a colored line will
appear in test line region 1. In the IgM component, anti-ligand is
coated in test line region 2 of the test. During testing, the
specimen reacts with ligand anti-human IgM. Dengue IgM antibodies,
if present in the specimen, reacts with the ligand anti-human IgM
and the Dengue antigen-coated particles in the test strip, and this
complex is captured by the anti-ligand, forming a colored line in
test line region 2.
Therefore, if the specimen contains Dengue IgG antibodies, a
colored line will appear in test line region 1. If the specimen
contains Dengue IgM antibodies, a colored line will appear in test
line region 2. If the specimen does not contain Dengue antibodies,
no colored line will appear in either of the test line regions,
indicating a negative result. To serve as a procedural control, a
colored line will always appeared in the control line region,
indicating that the proper volume of specimen has been added and
membrane wicking has occurred.
PERFORMANCE CHARACTERISTICS
1. Clinical Performance For IgM Test
A total of 314 patient samples from susceptible subjects were
tested by the Dengue IgG/IgM Rapid Test and by a reference EIA.
Comparison for all subjects is showed in the following table:
| Dengue IgG/IgM Rapid Test | |
| IgM EIA Test | Positive | Negative | Total |
| Positive | 31 | 1 | 32 |
| Negative | 3 | 279 | 282 |
| Total | 34 | 280 | 314 |
Relative Sensitivity: 96.9%, Relative Specificity: 98.9%, Overall
Agreement: 98.7%
2. Clinical Performance For IgG Test
A total of 326 patient samples from susceptible subjects were
tested by the Dengue IgG/IgM Rapid Test and by a reference EIA.
Comparison for all subjects is showed in the following table:
| Dengue IgG/IgM Rapid Test | |
| IgG EIA Test | Positive | Negative | Total |
| Positive | 36 | 1 | 37 |
| Negative | 2 | 287 | 289 |
| Total | 38 | 288 | 326 |
Relative Sensitivity: 97.3%, Relative Specificity: 99.3%, Overall
Agreement: 99.1%
