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

Lower the risk

Testing of IgM and IgG Antibodies gives a second opinion if symptoms are experienced and the PCR test is negative.

Simple

Easy to perform, result in 15 minutes

Precision

The sensitivity of the Antibody Rapid Test Kit can reach 99.1%, which can help to identify the cause for a missed PCR detection caused by suboptimal sample acquisition.

Facts

Qualitativer Immunoassay auf Membranbasis (Colloidal Gold). Dieser Test besteht aus drei Testlinien, einer IgM-Linie, einer IgG-Linie und einer Kontrolllinie. Wenn die Probe spezifische Antikörper gegen COVID-19 enthält, die durch die Immunantwort des Individuums gegen SARS- CoV-2 erzeugt werden, erscheint eine farbige Linie im jeweiligen Nachweisbereich der IgM- und / oder IgG-Bande. Die Kontrolllinie muss in allen Fällen erscheinen auch wenn die IgM- oder IgG- Linien nicht angezeigt werden.

The test is intended for medical professional and laboratory use.

Indication for Testing

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 – Different Stages

 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-ABRT (Kit with 25 tests)
Price:  From 5,20€ per test

Operation Procedure

Result Interpretation

AIgM(-) & IgG(+)Positive Indication of a past Infection
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%]