Assure (Fastep) COVID- 19 IgG/IgM Rapid Test Device
CLIA Number required and it will be checked before the order is sent
FDA Authorizes Point-of-Care Antibody Test for COVID-19 Rapid results within 15 minute – 20 Tests Per Box
This test can be performed and results within 15 mins.
Our POC authorized finger stick blood samples can be tested in point of care settings.
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Assure (FaStep) COVID- 19 IgG/IgM
Coronavirus Rapid Test
Professional use only
FDA Authorizes First Point-of-Care Antibody Test for COVID-19
EUA POC/CLIA Waived COVID19 Antibody test
Finger Prick Test Covid 19 antibody test kit
Kit Includes 20 Tests w/ 3ml buffer
This test is for professional ‘point-of-care’ use only
Verification of NPI# will be required upon purchase.
AS LOW AS $5.99ea IN QUANTITY
FREE SHIPPING ON ALL ORDERS
Coronavirus Rapid Test (COVID-19 IgG/IgM Test) Kit
COVID-19 IgG/IgM 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 Test (COVID-19 IgG/IgM) 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.
Level: Laboratory Update
FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations:
For more information, visit this FDA Web page, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.
Device: Assure COVID-19 IgG/IgM Rapid Test Device
Company: Assure Tech.
Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA),
serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: 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.
Individually Packed Test Device
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under a EUA for use by authorized laboratories;
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
What is Coronavirus?
Coronaviruses are a kind of infection. There are a wide range of varieties. 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.
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 FDA. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of IgM and IgG antibodies against SARS–CoV-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.
For IgM detection:
|COVID-19 IgG/IgM Rapid Test||IgM+||74||2||76|
For IgG detection:
|COVID-19 IgG/IgM Rapid Test||IgG+||82||3||85|
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.
IgG Positive:*The colored line in the region of control (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 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.
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 and then repeat the procedure with new test device. If the problem persists, stop using the test kit instantly and contact your supplier.
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.
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.
Coronavirus Rapid Test (IgG/IgM) Instructions for Use
- 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.
- Place the test device on a clean and level surface.
- (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.
- 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).
- 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.