Antibody Rapid Test Kit

SARS COV-2 IgG / IgM Antibody Rapid Test Kit

Product characteristics​

Flexibility

10 µL Serum Plasma, Whole blood or Peripheral blood can be used as sample

Simple

Easy to perform, result in 15 minutes

Intendet use
The SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant). The product is intended for the determination of the immunological status against SARS-CoV-2 after infection or vaccination. At this time, it is unknown for how long antibodies persist following infection or vaccination and if the presence of antibodies confers protective immunity. The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit should not be used to diagnose acute SARS-CoV-2 infection. Testing is intended to be performed by medical professionals or by individuals trained by these. Results are for the detection of SARS-CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days（typically between 7-10 days）after initial infection, although the duration of time antibodies are present post-infection is not well characterized.
Test principle
The SARS-CoV-2 IgM/IgG Antibody Test is based on the immunochromatographic method. The anti-SARS-CoV-2 IgM and IgG is detected by recombinant SARS-CoV-2 S-protein and N-protein, each labelled with colloidal gold in the mobile phase and by using mouse anti-human IgG/IgM coated on the nitrocellulose (NC) membrane. The internal quality control is achieved by using a rabbit IgG polyclonal antibody labelled with colloidal gold in the mobile phase and goat anti-rabbit polyclonal antibody coated on the NC membrane (C line). The antibodies which the patient has raised against the SARS-CoV-2 virus react with the colloidal gold S-protein and/or N-protein conjugates and form an immune-complex. These migrate along the membrane and reach the IgM (M) and the IgG (G) test lines. At the test lines the bound anti-IgG or anti-IgM capture the immune-complex formed between the relevant antibodies and the recombinant N and/or S protein. When the result is positive, the gold-labelled SARS-CoV-2 recombinant antigen-antibody complex binds to the IgM/IgG test line (T) and a purplish red color develops. When the result is negative, the sample does not contain any SARS-CoV-2 recombinant N or S-protein antigen-antibody complex that can bind to the IgM/IgG test line (T) so no color becomes visible. Development of a purplish red control line (C) guarantees that sample application and migration have taken place correctly and that the test was properly performed.
The test is intended for medical professional and laboratory use.

Indication for Testing

For current antibody vaccination status:
4 to 5 days after a PCR test was done to identify the associated antibody status
4 to 5 days after symptoms have been experienced.
If no PCR test is accessible.
As a precaution in case of uncertainty if infection took place.
As a follow up of positive detected patients to monitor the status of the IgM / IgG antibodies
After vaccination to monitor the development and status of antibodies

SARS-CoV-2 IgM / IgG antibody test after a successful vaccination

No earlier than 14 days after the second vaccination dose (three weeks after vaccination for Johnson & Johnson vaccines).

SARS-CoV-2 IgM / IgG Antibody Test – Different Stages after infection

IgGIgM
Days from onset of symptomesPCR positive at any timeSamples with positive results (Serum)PPA*95% CISamples with positive Results (Serum)PPA*95% CI
≦71200433.3313.81%-60.93%
8-14533056.6%43.26%-69.05%4483.02%70.78%-90.80%
≦1513212796,2191.43%-98.37%12997.73%93.53%-99.22%
Total197

Sample source: Samples were collected from 197 serum samples of 40 patients with COVID-19 on 1-7 days, 8-14 day and at least 15 days after the onset of the disease to evaluate the coincidence rate of IgM / IgG over time.

Kit Content

NoContentQuantity
1Instructions for use1 copy
2Test Cassette25 cassettes
3Sampler Diluent ( Phospate buffer containing casein)1 vial
4Dropper25 dropper
Product NameSample TypeStorage TemperaturePackaging Size
SARS COV-2 IgG / IgM

Antibody Rapid Test Kit		Serum, Plasma,

Whole Blood		Store at 2°C – 30°C25Tests / Kit

Order Number:  S-CoV-2-ABRT20 (Kit with 25 tests)
Price:  From 3,20€ per test

Operation Procedure

Result Interpretation

AIgM(-) & IgG(+)Positive Indication of a past Infection or positive antibody vaccination status
BIgM(+) & IgG(-)Positive Indication of an acute Infection
CIgM(+) & IgG(+)Positive Indication of an ongoing Infection
DIgM(-) & IgG(-)Negative
ENo ControlINVALID

SARS-CoV-2 IgM / IgG Antibody Test – Sensitivity

SARS-CoV2 Positive Samples
Clinical site(s)Hefei CDC, Fuyang CDC, Anhui Province CDC, ChinaYale New Haven Hospital, New Haven, CT, USA
Infection time1-14 days>14 days1-14 days>14 days
Sample quantity294118319
IgM/IgG positive134111249
IgM positive133111249
IgG positive103109249
None160770
Sensitivity-IgM/IgG [95%CI]45.6% [39.8-51.46]94.1% [88.2-97.6%]77.4% [59.9%-90.4%]100% [66.4-100%]
Sensitivity-IgM[95%CI]45.2% [39.5-51.1]94.1% [88.2-97.6%]77.4% [59.9%-90.4%]100% [66.4-100%]
Sensitivity-IgG[95%CI]35.0% [29.6-40.8]94.4% [86.0-96.5%]77.4% [59.9%-90.4%]100% [66.4-100%]

SARS-CoV-2 IgM / IgG Antibody Test – Specificity

SARS-CoV2 Negative Samples
Clinical site(s)Hefei CDC, Fuyang CDC, Anhui Province CDC, ChinaHefei, Fuyang,

Anhui Province, CHINA		New Haven, CT, USA
Sample TypeOther respiratory samplesPregnant womanInpatient’s in other departmentsPhysical ExaminationHealthy controlsHealthy controls
Sample quantity28141625211233641
IgM positive620031
IgG positive000010
None27541425211233340
Specificity – IgM [95%CI]97.9%

[95.4-99.2%]		99.5%

[98.3-99.9%]		100%

[98.6-100%]		100%

[96.8-100%]		99.1%

[97.4-99.8%]		97.6%

[87.1-99.9%]
Specificity – IgG [95%CI]100.0%

[98.7-100%]		100%

[99.1-100%]		100% [98.6-100%]100%

[96.8-100%]		99.7%

[98.4-99.9%]		100%

[91.4.4-100%]

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