Description
PRODUCT DESCRIPTION
CFUSSeries1000includes both antibody positive and negative reference materials. The positive is manufactured from human serum or plasma reactive for SARS-CoV-2IgG/IgM andnonreactiveforHBsAg and antibodies to HIV 1and 2, HTLV I and II, and HCV. There is a single vial of positive reference material (red cap) contained within each kit. The negative reference material is manufactured from human serum or plasma non-reactive for antibodies to SARS-CoV-2,aswellasHBsAgandantibodies to HIV 1 and 2, HTLV I and II, and HCV. There is a single vial of negative reference material (clear caps) contained within each kit. PACKAGE DETAIL: Positive (Redcaps): 1×1.0mLvials Negative(Clearcaps): 1 x 1.0 ml vials This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin® (5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as preservative
INTENDED USE
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) early after infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different as appropriate, IgG or IgM assay.
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Product Features:
- Rapid Detection: result is ready within 10 minutes
- Simple Operation: no professional training required and accessible in basic labs
- Easy Sampling: whole blood, serum or plasma
- Qualitative Test: no additional equipment required or specialized lab
Packaging : 25pcs/box
MOQ : 1,000pcs
