We urge world to 'test, test, test' for COVID-19

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10 MINUTES

Covid-19 Rapid IgG/IgM combined Antibody assay Pre screening test Kit

Kit Model # FERCSSO5310

No lab visits, no doctors
Just one finger prick of blood
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Screening is Critical for Community Pulse.

"We urge world to 'test, test, test' for COVID-19"

Current method

Our Method

Pre Screening

Benefits

of pre-screening

Exponentially faster
No Queues, No Wait time for results
Exponentially more cost effective
Early Detection & Elimination
Effort less, and accessible to everyone
nationwide, instantly
Viable precautionary step

Detection Period

10 MINUTES

Easy operation without requirement of any
Doctor or Professional Nurse

No special equipment storage and transportation
conditions required

Works with whole blood, serum, and plasma
Tests for 2 antibodies IgM and IgG
simultaneously

Instant Field screening

100% Accurate
in detecting Corona Virus antibodies.
99.31% Accurate in ruling them out.

Current Distribution

Worldwide approximate

  • Italy
  • Spain
  • Germany
  • UK
  • Czech
  • Swiss
  • Korea
  • China
  • Lebanon
  • Japan
  • India
  • Netherlands
  • UAE
  • Indonesia
  • South America

PLUS 27 more countries
and growing rapidly daily

FDA PEUA
CE European Approval Certified
ICMR Recommended

Discover if you are exposed in 10 minutes?

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Effective Use

  • Hospitals
  • Corporate CSR
  • Physicians Clinics
  • Community Doctors
  • Doctors Without Borders
  • Practicing Doctors
  • General Practitioners
  • Nurses and Professionals
  • Ayurvedic and Homeopathic Doctors
  • Alternative Medicine
  • Integrative Medicine Practitioners
  • Emergency Response Teams
  • Governmental Institutions
  • Clinical Researchers

Detection

Process

It is widely accepted that IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid screening of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas 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.

Fluorescence PCR CLIA "Colloidal Gold Method (our method)"
Detection substance Nucleic acid Antibody Antibody
Type of sample "Nasopharyngeal swabs, sputum, alveolar lavage fluid " Serum/ Plasma Serum/ Plasma/ Whole blood
Time to get result 2 hrs 20 mins Fastest 10 minutes
Instrument needed or not Yes Yes, i 3000, i 1000 Not needed
Laboratory requirement High Relatively high Average
Product Usage Confirming diagnosis Nucleic acid negative sample reviewing or high-volume sample detection Nucleic acid negative sample reviewing or basic hospital sample testing
Colloidal Gold Method: The 2019-nCOV IgG/IgM Rapid Test Device using this Method is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of Coronavirus in human whole blood, serum, or plasma

RT-PCR Vs Covid19 IgG/IgM Rapid Test
Comparative Test Summary

The Covid-19 IgG/IgM rapid test and the SARS-CoV-2 RT-PCR test were detected simultaneously and the Sensitivity (positive coincidence rate), Specificity (negative coincidence rate), and Accuracy (total coincidence rate) were calculated:

In this clinical trial, total, 547 test samples (258 positive and 289 negative) were included for the unit and all test samples included are tested. Statistics on test results and those of the product tested at >/= 15 days after onset of symptoms are as follows:

Antibody Specificity Sensitivity
IgG 99.31% 100%
IgM 97.58% 92%

Cross-reactivity

Cross-reactivity of Covid-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit was evaluated with Positive serum specimens of different respiratory diseases.

No false positivity or false negativity was found with the following:

HBsAg Influenza A
FLU-A Influenza B
FLU-B TP
HCV Respiratory syncytial virus (RSV)
HIV-1 RF
HIV-2 Chlamydia pneumonia (CP)
Adenovirus Mycoplasma pneumonia (MP)
Parainfluenza virus 1-4

Potentially Interfering Substances

The following substances have been tested using Covid-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Test Kit to evaluate potential endogenous interference. The IgM positive, IgG positive and negative samples were used to dilute the interferents to following concentrations.

Interfering substances Concentration
Ascorbic acid 0.2mg/ml
Hemoglobin 10mg/ml
Bilirubin 0.6mg/ml
Oxalic acid 1mg/ml
Human serum albumin 20mg/ml
Triglyceride 50mg/ml
How Does an Antibody Test Work?
The COVID-19 IgM/IgG antibody rapid test is a fast and effective method for screening IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information on the stage of infection.

Both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies are produced during the primary immune response. As the body’s largest antibody, IgM is the first antibody to appear in response to an initial exposure to antigens. IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. IgG is usually detectable about 7 days after the IgM appears.
How is the COVID-19 IgM/IgG Rapid Test Kit different from Real-Time RT-PCR test?
The Real-Time RT-PCR (nucleic acid test) for SARS-CoV-2 is based on the detection of viral RNA, and it is the gold standard for COVID-19 diagnosis. The results for this nucleic acid test might take up to 3.5 hours, and the increased complexity of viral RNA extractions and PCR reaction setups require highly trained laboratory personnel. The COVID-19 IgM/IgG antibody rapid test is a qualitative test for COVID-19 IgM and IgG antibodies to. It is less complex and can provide results in less than 10 minutes. However, it should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status
What are the limitations of Antibody tests?
1. COVID-19 Rapid Test is for in vitro diagnostic use only. The test should be performed using serum, plasma or whole blood samples only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test.
2. In the early onset of fever, anti-COVID-19 IgM concentrations may be below detectable levels.
3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
4. Results from immunosuppressed patients should be interpreted with caution.
5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
6. If the test result is negative and clinical symptoms persist additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
Why Do We Need Antibody Testing?
You could have SARS-CoV-2 and not know it. Not everyone who gets it has symptoms. Experts hope antibody tests can give health officials a better idea of how common the virus is.

Once scientists know who has had the virus, they can find out how sick it makes most people. And they can study what happens if people who've had it come into contact with it again. Along with other scientific information, this can help researchers understand who might be immune to the virus.

The hope is that people with antibodies to COVID-19 can safely get back to work, and normal life, quicker.

These tests may also help with an experimental treatment for COVID-19 called convalescent plasma. Plasma is the liquid part of your blood.

Researchers are studying how antibodies in plasma donated by people who’ve recovered from COVID-19 might help those who are ill with the virus. One theory is that this plasma may help sick people get better faster. But more research is needed.

You can volunteer to donate plasma through the National COVID-19 Convalescent Plasma Project. Or ask your local blood donation center for information.
Is the test for Home Use?
This is not an over-the-counter product for home use. The test must be administered by a licensed medical professional. However, it is a POC (point of care) test that does not require sending samples to a lab. Therefore, the results can be obtained on-site at a clinic.
What is the limit-of-detection for this assay?
There is no known LOD of this assay. The kit is qualitative and is based on antigen-antibody interactions, and every person has different antibody affinities.
What is the difference between the finger prick and serum/whole blood kits?
The test cartridges and diluent provided in the finger prick and serum/whole blood kits are identical. The only difference is that the finger prick kit comes with materials necessary for capillary blood collection (lancets, alcohol swabs, bandages).
What kind of volume can you supply for these tests?
Yes, we can scale our production to meet your needs for upto 1.5 million kits per day. Our typical turnaround time is 5 business days to ship for larger volumes. For volumes under 500,000 we can ship within 2 business days.
Are these tests covered by insurance?
The billing code for non-CDC laboratory tests for SARS-CoV-2/COVID-19 is 86328. The patient's insurance company should be contacted to determine coverage and pricing.
Are the kits CE or FDA approved?
Our kits are CE approved.

These kits are FDA PEUA authorized. Our kits documentation for in vitro diagnostic use have been submitted for Emergency Use Authorization following guidance from the FDA on May 14, 2020. The tests have not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
Do I need a special analyzer to run the COVID-19 IgM/IgG Rapid Test?
No, the IgM/IgG rapid test does not require any other equipment. Aurora’s COVID-19 IgM/IgG Rapid Test Kit provides all the tools you need from sample collection to result reading.
What should I do if I my COVID-19 IgM/IgG Rapid Test is positive?
The COVID-19 Antibody Rapid Test can only be used as a reference, please contact your local physician or hospital.
Is each test packed separately and what components are included?
No, 25 test kits are packed in the box. Each Box includes: 25 COVID-19 IgM/IgG Rapid Test cassette, 25 disposable pipet, 25 lancets, 25 Alcohol swabs and 1 sample dilution buffer. Each box contains one copy of the Instruction manual.
Deloitte Deloitte John Hopkins OECD McKinsey & Company The Rockefeller Foundation EASA Department of Health & Social Care
John Hopkins Deloitte Deloitte OECD EASA McKinsey & Company The Rockefeller Foundation Department of Health & Social Care

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