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Coronavirus Rapid Test (Covid-19 IgG/IgM)

Professional use only – EUA Authorized  
POC (Point Of Care) – Finger Prick Test

 

Kit Includes 30 Tests and 3ml buffer
This test is for professional use only.
Verification of Medical use will be needed upon purchase.

 

AUTHORIZATION: Use of this test with all authorized specimen types is limited to
laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet
requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood
specimens only at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.

As low as $8.49ea in bulk
FREE SHIPPING on all orders

Rapid Covid Coronavirus Diagnostic

 

Coronavirus Rapid Test (COVID-19 IgG/IgM) Kit

Ovus Medical is pleased to provide a Coronavirus Rapid Test (Covid-19) Device.

The coronavirus screening kit includes everything necessary for the detection of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood. This test kit will provide results in as little as 15 minutes!

What is a Coronavirus Rapid Test (COVID-19 IgG/IgM) ?

This is a blood test that detects immune proteins (antibodies) within the body.  By detecting these antibodies, it will determine whether the body has been detected by the COVID-19 Coronavirus (SARS-CoV-2).

What Does the Coronavirus Rapid Test (COVID-19 IgG/IgM) Device Detect?

Coronavirus Rapid Test Device is an in vitro immunoassay for the immediate and subjective location of hostile to SARS-CoV-s IgM and against SARS-CoV-2 IgG in human entire blood, serum or plasma as a guide in the finding of essential and second SARS-COV-2 diseases.

THIS TEST IS FOR PROFESSIONAL USE ONLY. VERIFICATION OF NPI# AND MEDICAL USE IS REQUIRED UPON PURCHASE.

 

Included Materials:

Package Insert

Buffer

Disposable Pipettes

Individually Packed Test Device

Coronavirus Rapid Test (IgG/IgM) Instructions for Use

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
  2. Place the test device on a clean and level surface.
  3. (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
  4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
  5. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

Clinical Evaluation:

 

For IgM detection:

Method PCR+ PCR- Total
COVID-19 IgG/IgM Rapid Test IgM+ 74 2 76
IgM- 5 225 230
Total 79 227 306

For IgG detection:

Method Convalescent samples PCR- Total
COVID-19 IgG/IgM Rapid Test IgG+ 82 3 85
IgG- 1 224 225
Total 83 227 310

Results interpretation:

IgM Positive:*The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgM test region. The result is positive for COVID-19 virus specific-IgM antibodies.

IgG Positive:*The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgG test region. The result is positive for COVID-19 virus specific-IgG antibodies.

IgM and IgG Positive:*The colored line in the control region (C) changes from blue to red, and two colored lines should appear in IgG and IgM test regions. The color intensities of the lines do not have to match. The result is positive for IgM and IgG antibodies.

Negative: The colored line in the control region (C) changes from blue to red. No line appears in IgM or IgG test regions.

Invalid: Control line (C) is still completely or partially blue, and fails to completely change from blue to red. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Antibody Test for IgG

This test recognizes IgG antibodies that formulate in many patients around 7 to 10 days after indications of COVID-19 start. IgG antibodies stay in the blood after infection has passed. These antibodies show that you may have had COVID-19 recently and have created antibodies that may shield you from future contaminations. It is unclear at this time how much protection antibodies may give against reinfection.

RESULTS IN UNDER 15 MINUTES

Antibody Test for IgM

This test identifies IgM antibodies. IgM is typically the primary antibody produced by the immune system when a virus attacks. A positive IgM test shows that you may have been tainted and that your immune system has started reacting to the virus. At the point when IgM is discovered you may even now be contaminated, or you may have recently recovered from a COVID-19 infection.

What is Coronavirus?

Coronaviruses are a kind of infection. There are a wide range of varities. A recently perceived coronavirus, SARS-CoV-2, has caused an overall pandemic of respiratory sickness, called COVID-19.

Coronavirus Symptoms include: Cough. Fever. Brevity of breath. Muscle hurts. Sore throat. Unexplained loss of taste or smell. Diarrhea. Migraine.

Seven human coronaviruses (HCoVs) have been so far recognized, prominently HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1, genuine intense respiratory disorder coronavirus (SARS-CoV), Middle East respiratory condition coronavirus (MERS-CoV) and the novel coronavirus (2019-nCoV, a.k.a. SARS-CoV-2).

In agreement to the profoundly pathogenic SARS-CoV, MERS-CoV, and 2019-nCoV, the four purported basic HCoVs for the most part cause moderate upper-respiratory tract sickness and add to 15%–30% of instances of regular colds in human grown-ups. Extreme and dangerous lower respiratory tract diseases can in some cases happen in the old, newborn children and additionally immunocompromised patients.

What Does the Coronavirus Rapid Test Device (COVID-19 IgG/IgM) Detect?

The Coronavirus Rapid Test Device (COVID-19 IgG/IgM) is an in vitro immunoassay for the immediate and subjective location of hostile to SARS-CoV-s IgM and against SARS-CoV-2 IgG in human entire blood, serum or plasma as a guide in the finding of essential and second SARS-COV-2 diseases.

FAQ

Who can purchase Coronavirus Rapid Test Device?

Coronavirus Rapid Test Device (COVID-19 IgG/IgM) is not for home use.  The use of this particular rapid test is limited to Health Care institutions and Medical Distribution Companies certified to perform high complexity testing.

Is the Coronavirus Rapid Test FDA Approved?

This test has not been reviewed by the FDAThis test has been authorized by FDA under an EUA for use by authorized laboratoriesThis test has been authorized only for the presence of IgM and IgG antibodies against SARSCoV-2, not for any other viruses or pathogens.

How accurate is Coronavirus Rapid Test Device?

The relative accuracy rate is 97%.

Are there temperature requirements for storage purposes?

The COVID-19 IgG/IgM Rapid Test Device should be stored at 35 – 86 degrees Fahrenheit when not in use.

What Does a Positive Detection Result Indicate?

Detection of IgM indicates a recent infection and can be used for early diagnosis of infection. IgG antibodies gradually appear and increase in the late stage of infection, and the COVID-19 IgG/IgM Rapid Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody. It will provide a presumptive diagnosis of COVID-19

Can the device be frozen for long-term storage?

The device should never be frozen. If refrigerated, allow the buffer, specimen, and device to reach room temperature before use. The advised storage is 2-30⁰C / 36-86⁰F.

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