uncut sheet for SARS-COV-2 IgGIgM Antibody Rapid Test
For professional and in vitro diagnostic use only.
| Product Name | uncut sheet for SARS-COV-2 IgGIgM Antibody Rapid Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow
chromatographic immunoassay for the qualitative detection of
antibodies (IgG and IgM) to Novel coronavirus in human Whole
Blood/Serum/Plasma. It provides an aid in the diagnosis of
infection with Novel coronavirus.
[PRINCIPLE]
The COVID-19 IgG/IgM Rapid Test device is a qualitative membrane
strip based immunoassay for the detection of antibodies (IgG and
IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The
test device consists of: 1) a burgundy colored conjugate pad
containing Novel coronavirus recombinant envelope antigens
conjugated with Colloid gold (Novel coronavirus conjugates), 2) a
nitrocellulose membrane strip containing two test lines (IgG and
IgM lines) and a control line (C line). The IgM line is pre-coated
with the Mouse anti- Human IgM antibody, IgG line is coated with
Mouse anti-Human IgG antibody. When an adequate volume of test
specimen is dispensed into the sample well of the test device, the
specimen migrates by capillary action across the device. IgM
anti-Novel coronavirus, if present in the specimen, will bind to
the Novel coronavirus conjugates. The immunocomplex is then
captured by the reagent pre-coated on the IgM band, forming a
burgundy colored IgM
line, indicating a Novel coronavirus IgM positive test result. IgG
anti-Novel coronavirus if present in the specimen will bind to the
Novel coronavirus conjugates. The immunocomplex is then captured by
the reagent coated on the IgG line, forming a burgundy colored IgG
line, indicating a Novel coronavirus IgG positive test result.
Absence of any T lines (IgG and IgM) suggests a negative result. To
serve as a
procedural control, a colored line will always appear at the
control line region indicating that proper volume of specimen has
been added and membrane wicking has occurred.
[PERFORMANCE CHARACTERISTICS]
Accuracy
If a person suffered the novel coronaviruses, there are several
stages before recovery, like window period, early stage, initial
stage, mid-term, and later period. The window period continues 14
days, 3-7days mostly, and no antibody produced at this time. Early
stage is about 1-7 days after onset, and the IgM antibody appears,
but the concentration is too low to be detected. Initial stage is
about 8-14 days after onset, the
IgM antibody increases and the IgG antibody appears. Mid-term is
about 15-39 days after onset, the IgM antibody decreases gradually
and the IgG antibody peaks. The later period is about 1-2 months
after onset, and IgM antibody could be detected hardly.
Also, everyone is different because of the difference of people’s
immune response. For example, the antibody concentration of older
people is higher than younger significantly, and the antibody
levels in Asymptomatic infected human body are low
generally. A side-by-side comparison was conducted using the Novel
coronavirus IgG/IgM Rapid Test and RT-PCR. 200 clinical specimens
from Professional Point of Care site were evaluated, 57 were
positive and 143 negative. In order to consider the difference of
antibody production in people after infection as much as possible,
we conducted 10 trails respectively. Base on the results from the
clinical studies, the statistical analysis was made as follows:
COVID-19 IgM: the average sensitivity is 81.38% (95% CI:
70.18%~92.58%), the average specificity is 93.93% (95% CI:
88.23%~99.62%) and the total accuracy is 90.67% (95% CI:
87.07%~94.26%).
COVID-19 IgG: the average sensitivity is 92.50% (95% CI:
87.65%~97.35%), the average specificity is 95.53% (95% CI:
92.01%~99.06%) and the total accuracy is 94.67% (95% CI:
91.57%~97.77%).
Cross-Reactivity and Interference
1. Other common causative agents of infectious diseases were
evaluated for cross reactivity with the test. Some positive
specimens of other common infectious diseases were spiked into the
Novel coronavirus positive and negative specimens and tested
separately. No cross reactivity was observed with specimens from
patients infected with HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB,
RSV and TP.
2. Potentially cross-reactive endogenous substances including
common serum components, such as lipids, hemoglobin, bilirubin,
were spiked at high concentrations into the Novel coronavirus
positive and negative specimens and tested, separately. No cross
reactivity or interference was observed to the device.
