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SARS-CoV-2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma),Test with LF Reader
Product features
Parameters
Principle
Chromatographic Immunoassay
Format
Cassette
Specimen
WB/S/P
Certificate
CE
Reading Time
10 minutes
Pack
25T
Storage Temperature
2-30°C
Shelf Life
2 Years
Application
A rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimens that can be performed with the use of the Citest LF Reader. For professional in vitro diagnostic use only.
INTENDED USE
The COVID IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of SARS-CoV-2 infection by a healthcare provider.
The COVID IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID IgG/IgM Rapid Test should not be used as the sole basis for
diagnosis.
Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID IgG/IgM Rapid Test early after infection is
unknown.
False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.
PRINCIPLE
The COVID IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region.
During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to SARS-CoV-2. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to SARS-CoV-2, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result.
Therefore, if the specimen contains SARS-CoV-2 IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains SARS-CoV-2 IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain SARS-CoV-2 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 appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.
2. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
3. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 10uL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80uL) to Buffer well(B) , and start the timer.
Use a pipette: Transfer 10 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL) to Buffer well(B), and start the timer
For Venipuncture Whole Blood specimen:
Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 uL) to Buffer well (B) and start the timer.
Use a pipette: Transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL) to Buffer well(B), and start the timer
For Fingerstick Whole Blood specimen:
Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 uL) to Buffer well (B) and start the timer.
Use a capillary tube: Fill the capillary tube and transfer approximately 20uL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80uL) to Buffer well (B) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results should be read with the Citest LF Reader at 10 minutes.
5. Do not interpret test results visually.
PRECAUTIONS
1. This package insert must be read completely before performing the test. Failure to follow directions in insert may yield inaccurate test results.
2. For use exclusively with the LF Reader. Do not interpret test results visually.
3. For professional in vitro diagnostic use only. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not use test if package is damaged.
6. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
7. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
8. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
9. The used test should be discarded according to local regulations.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Exporter,Trading Company
Total Annual:
80000000-100000000
Employee Number:
500~10000
Ecer Certification：
Verified Supplier
CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.
... CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.
...
