COVID-19 lgG/IgM Test (Test with Fluorescence Immunoassay
Analyzer),COVID-19 Antibody Fluorescence Immunoass Test Range
Application:
The COVID-19 lgG/IgM Test is a Fluorescence Immunoassay qualitative
detection of IgG and IgM antibodies to SARS-CoV-2 in human whole
blood, serum or plasma with the use of FIATEST Fluorescence
Immunoassay Analyzer as an aid in the diagnosis of COVID-19
infection.
| Product Name: | COVID-19 LgG/IgM Test (Test With Fluorescence Immunoassay
Analyzer),COVID-19 Antibody Fluorescence Immunoass Test Range |
| Format: | Cassette |
| Certificate: | CE |
| Pack: | 10T/25T |
| Shelf Life: | 2 Years |
| Objective: | Results Read By Analyzer |
| Principle: | Fluorescence Immunoassay |
| Specimen: | Nasopharyngeal Swab |
| Reading Time: | 10-15 Minutes |
| Storage Temperature: | 2-30℃ |
| Fast Result: | 10-15 Minutes |
| High Efficiency: | Both STAT Testing And Batch Testing |
Description:
The IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) is a
qualitative, lateral flow immunoassay for the detection of human
IgE antibody in whole blood, serum or plasma specimens. In this
test, mouse anti-human IgE is coated in the test line region of the
test. During testing, IgE present in whole blood, serum or plasma
specimen reacts with mouse anti-human IgE coated particles in the
test strip. The mixture then migrates forward on the membrane by
capillary action and reacts with the mouse anti-IgE on the membrane
in the test line region. The presence of a colored line in the test
line region indicates a positive result for IgE, while its absence
indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear
in the control line region of the strip indicating that proper
volume of specimen has been added and membrane wicking has
occurred.
PRODUCT FEATURES
【PERFORMANCE CHARACTERISTICS】 1. Accuracy The test deviation is ≤±20%. 2. Assay Range and Detection Limit Assay Range: 20 – 1600 IU/ml Minimum Detection Limit (Analytical Sensitivity): 20 IU/ml 3. Linearity Range 20 – 800IU/ml, R≥0.990 4. Precision Intra-lot precision C.V. is ≤ 15% Inter-lot precision C.V. is ≤ 20% |
Fast Result (15 minutes) Simple Operation (Less Training Required) Objective (Results Read by Analyzer) Stringent Quality Control Insure High Accuracy User-friendly (Simple Plug & Play Operation) High Efficiency (Both STAT Testing and Batch Testing)
|
【INTERPRETATION OF RESULTS 】
(Please refer to the illustration above)
POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region
(C) and another line should be in the test line region.
*NOTE: The intensity of the color in the test line region may vary
depending on the concentration of human IgE antibodies present in
the specimen. Therefore, any shade of color in the test line region
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the
procedure and repeat the test with a new test. If the problem
persists, discontinue using the test kit immediately and contact
your local distributor.
