Coronavirus (SARS-CoV-2) IgM Antibody Rapid Test Kit

DESCRIPTION:

The SARS-CoV-2 IgM/IgG Ab Rapid Test is used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

DESCRIPTION: The QuantiVirus™ SARS-CoV-2 Test Kit is based on Real-Time PCR (RT-PCR) technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum. The sensitivity is 100 copies per mL of SARS-CoV-2 viral with a 95% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.

  • 82% Positive coincidence rate
  • >96% Negative coincidence rate
  • 92.6% Total coincidence rate

COVID-19, it is a novel coronavirus with new strain that has not been previously identified in humans, belongs to Coronaviruses (CoV) such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome(SARS-CoV).

Approved in Australian Register of Therapeutic Goods (ARTG)

FDA EUA approval in process

All certificates available upon LOI

  • This device when assessed and examined against harmonized standard EN149 was found to be in conformity with the expanded FDA and CDC regulations relating to personal protective equipment (PPE)

TECHNICAL INFORMATION:

The test has been widely used by the Chinese CDC to detect infections and is now available in Switzerland. After cases have been detected outside of China. This test detects both the early marker and the late marker IgM/IgG antibodies in whole blood samples or simply with a finger prick like glucose tests. It can be used in symptomatic and/or asymptomatic patients. The test is ideal for quick and reliable verification tests by healthcare professionals.

Specifications:

  • Works with whole blood or plasma.
  • Detects IgM and IgG antibodies
  • Validated using PCR
  • 15 minutes per test
  • Intuitive visual interpretation
  • No special equipment needed, all included
  • No sample transport needed, may be performed in situ by healthcare professionals.

 

Applications of Coronavirus Test Kit COVID-19 IgG IgM – Pack 25 tests

  • General population screening
  • Allows rapid examination and diagnosis
  • Designed for healthcare professionals: Hospitals, medical, pharmacies, offices, laboratories
  • Can detect carriers that are asymptomatic
  • It can determine whether the patient was recently affected by the virus, even if the virus is no longer present.

How to use depending on whether you use blood or plasma

Result interpretation

A total of three detection lines are possible, the control line (C) appears when the sample is correct.

  1. IgG and IgM Positive: The colored line in the control line region (C) appears and two colored lines should appear in test line regions G and M (G and M). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary COVID-19 infection.
  2. IgG Positive: The colored line in the control line region (C) appears and a colored line appears in test line region G (G). The result is positive for COVID-19 specific-IgG and is probably indicative of secondary COVID-19 infection.
  3. IgM Positive: The colored line in the control line region (C) appears and a colored line appears in test line region M (M). The result is positive for COVID-19 virus specific-IgM antibodies and is indicative of primary COVID-19 infection.
  4. Negative result: If only the quality control line (C) appears and the IgG and IgM detection lines are not visible, then the new coronavirus has not been detected and the result is therefore negative.

Changes in Antibodies Levels

IgM appears first after infection with the virus and then IgG in the middle and late stages of infection.

IgM/IgG antibody test can determine if a patient is infected “recently 2019-nCoV”. It is widely known that IgM provides the first line of defense during viral infections, followed by adaption generation, high IgG affinity response for long-term immunity and immune memory.

Therefore, the test of COVID-19 IgM and IgG antibodies is an effective method for rapid diagnosis of COVID-19 infection. In addition, detection of IgM antibodies against COVID-19 tends to indicate recent exposure to COVID-19. While detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection.

KIT CONTENTS

  • Individually packaged test units X the number of kit tests: 1/25/40
  • Disposable pipettes X the number of kit tests: 1/25/40
  • Buffer (one container with sufficient content for Kit units: 1/25/40)
  • Instructions guide

MINIMUM ORDER QUANTITY: 50,000 Tests
TOTAL TESTS PER PACK: 25

ASIAN AIR FREIGHT PALLET SIZE:
PALLET BUILD HEIGHT:
PALLET WEIGHT with Product:
(without physical pallet weight included)

Standard Shipping Time: 7-12 Days
Expedited Delivery Available: Air Courier/CIF
(Due to demand and cost of materials, prices and availability subject to change)

Product manufactured in ISO 13485: 2016 certified facilities.

DUNS

117519312

TX HUB CERT # 185081721200

MBE CERT #AU04411

NACIS

423450, 325212,

315280, 339113,

315210, 622120,

621111, 339112

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