The Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)

  • Sample type: Serum, Plasma, Venous whole blood
  • Pack Size:10 Test Sets /Kit; 20 Test Sets /Kit
  • Storage Condition:2℃~30℃
    Interpretation of Test Result:15 minutes to interpret the result
  • Detection mode: Single detection, separate detection of IgM and IgG, the two results are non-interference and can complement each
    other
  • China Registration: National Medical Products Administration approval No.20203400240
  • International Registration: CE mark
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STOREAGE

  • Store at 2 – 30 °C
  • Keep dry and keep in dark place
  • The test should be finished within 30 minutes after the aluminum foil bag is unsealed. In case of the ambient temperature is above 30 °C or
    humidity is above 70%, it should be used as soon as possible.
  • The manufacturer date and expiration date can be found in the label of the kit.

SAMPLE COLLECTION, HANDLING and STORAGE

  • The product can be used for testing serum, plasma or venous whole blood samples.
  • Specimens should be collected by standard protocol.
  • The plasma or venous whole blood sample to be tested can be anticoagulated with sodium citrate, EDTA-K or heparin sodium.
  • Sample with Hemolysis, high viscosity, high fat, bacteria growth or contaminated are not suitable for this test kit.
  • Serum or Plasma samples can be stored at 2-8 °C for 7 days. For long term storage, the samples should be kept at -20 °C and repeated freezing and thawing should be avoided. The venous whole blood samples is recommended to be tested within 5 days and stored at 2-8 °C. Frozen storage
    is prohibited.

P R I N C I P L E

This test kit contains one IgM test cassette and one IgG test cassette, using the Colloidal Gold Immunochromatography technology to detect the Coronavirus (SARS-CoV-2) IgM/IgG antibody

IgM test cassette

  • The anti-human IgM antibody labeled by Colloidal gold is coated on the conjugate pad.
  • The antigens of Coronavirus (SARS-CoV-2) are coated in the test area.
  • The goat anti-mouse antibody is coated in the control area.

IgG test cassette

  • The anti-human IgG antibody labeled by Colloidal gold is coated on the conjugate pad.
  • The antigens of Coronavirus (SARS-CoV-2) are coated in the test area.
  • The goat anti-mouse antibody is coated in the control area.

While testing, the IgG antibody in the sample (Plasma, Serum, Whole blood) or Specific IgG antibody to Coronavirus (SARS-CoV-2) and non-specific IgG antibody binds with the colloidal gold labeled antihuman IgG antibody and forms an immune complex. The immune complex moves along the membrane through chromatography. If there is specific IgG antibody of Coronavirus (SARS-CoV-2) in the sample, it will be captured by the antigens coated in the test area to form a visible band (Test line). The free colloidal gold conjugated or immune complex continues to move forward and binds with the goat anti-mouse antibody coated in control area forming the visible band in control line.

One Step Rapid Test for Diagnosis of COVID-19

Much easier and faster to test On-Site

Rapid and Easy, Auxiliary test for diagnosis of Covid-19

Ideal complement to Coronavirus Nucleic acid Tests to avoid misdiagnosis

Possible to find asymptomatic carriers and to confirm the hospital discharge

Independent IgM and IgG results in one kit, capable to confirm of Covid-19

(according to the Diagnosis and treatment protocol for Novel Coronavirus Pneumonia 7th edition by The National Health Commission of P.R. China)

Abundant Clinical Validation Shows Excellent Diagnostic Performance

  • The test kit can only be used for in Vitro test of individual’s serum or whole blood samples.
  • The test result is only for clinical reference and should not be regarded as the only reference for clinical diagnosis and treatment. The clinical management for patients should be considered in combination with their symptoms, physical signs,medical history and other lab tests, and others.
  • The value of serological antibody test is limited in patients with impaired immune functions or receiving immune suppressive therapy.
  • IgM antibody positive not only occurs in primary infection, but also in secondary infection.
  • The accuracy of the test depends on the sample collection process, improper sample collection, improper sample storage or repeated freezing and thawing of the sample will affect the test result.
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Samples which show IgM and IgG positive to the following agents are tested with the kit, The results showed “No Cross Reactivity”.

Abundant Clinical Validation Shows Excellent Diagnostic Performance

Recognized in China Top Tier Hospitals

  • Wuhan Jinyintan hospital (First Designated COVID-19 hospital in the world)
  • The first affiliated hospital of Guangzhou Medical University
  • Peking Union Medical College Hospital
  • West China hospital Sichuan University
  • Shanghai public health clinical centre
  • Guangzhou eight peoples hospital
  • Huashan hospital fudan university
  • Ruijin hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai General Hospital
  • Zhuhai people’s hospital
  • The Fifth affiliated hospital Sun Yat Sen university
  • Chongqing public health medical center/ Southwest University public health hospital
  • Wuhan Pulmonary hospital
  • And more

Purchase Orders from Government & National Tenders

  • Czech Republic
  • Denmark
  • Brazil
  • Spain
  • Russian
  • Indonesia
  • WHO FIND Dx Program
  • Sweden
  • France
  • USA
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