• 2 SHIELD N-100 100% TOTAL PROTECTION 3G

    $12.00

    2 SHIELD N-100 100% TOTAL PROTECTION 3G

    $12.00

    QUICK OVERVIEW

    Out of stock

    Read more
  • Sale!

    CORONAVIRUS-COVID-19RapidTest

    $25.00 $16.50

    FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
    (For Medical Professional Use Only)

    FDA Emergency Use Authorized Coronavirus (COVID-19) Instant Test Kits
    FDA Emergency Use Authorization (EUA)
    Rapid results within 10 minutes
    Small sample size
    Sold in packs of 25
    Shelf life of up to 24 months from manufacture date
    Test to be performed in a CLIA moderate- or high-complexity setting *
    Verification of use case prior to shipping is mandatory
    Interested in IgG and IgM Controls? Inquire here for availability
    Watch this video to see how the COVID-19 Rapid Test works →
    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.

    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 detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Act, 21 U.S.C. $360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    * The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.

    To request more information about our Rapid Coronavirus (Covid-19) test kit-such as the product insert or the CE documentation, please complete the form below.

    Sold in counts of 25, minimum of 25 units for all orders.

    First Name (required)
    Last Name (required)
    Email (required)
    Direct Phone Number (required)
    City (required)

    State (required)
    Business Name (required)
    Industry (required)

    Are you a medical professional or medical facility? (required)

    Desired quantity of test kits (required)

    Coronavirus Symptoms
    COVID-19 presents numerous symptoms that can range from mild to severe. Testing is the best solution to detect the virus that causes COVID-19.

    The most common symptoms include:

    Cough
    Fever or chills
    Shortness of breath or difficulty breathing
    Muscle or body aches
    Sore throat
    New loss of taste or smell
    Diarrhea
    Headache
    Fatigue
    Nausea or vomiting
    Congestion or runny nose
    *these symptoms are very common and can occur in many conditions other than COVID-19

    If you are experiencing any of the above symptoms seek medical attention immediately to determine your exposure to Coronavirus.

    Can you have coronavirus symptoms without the fever?
    It is possible to be infected with the new coronavirus and have a cough or other symptoms with no fever, or a very low-grade one, especially in the first few days. Keep in mind that it is also possible to have COVID-19 with minimal or even no symptoms at all. (John Hopkins Medicine)

    Confirm BioSciences is proud to offer coronavirus testing solutions to help identify or rule out infection.

    COVID-19 IgG/IgM Rapid Test Cassette
    The Novel Coronavirus testing kit manufactured by Healgen Scientific LLC is conducted by using whole blood/serum/plasma and placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled “B.” Results should appear within 10 minutes and are invalid after 15 minutes. For more information, watch our video.

    Clinical Evaluation Results:
    Study 1: Healgen Clinical Agreement Validation
    The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2). At Site #1, 61 retrospective specimens and 4 prospective specimens were included in the study. At Site #2, 95 retrospective specimens and 31 prospective specimens were included in the study. The time from RT-PCR result to collection of specimens (plasma) ranged from 15-45 days (Site #1) and 0-38 days (Site #2). The time from collection of specimens (plasma) from each individual to testing ranged from 12-23 days (Site #1) and 3-29 days (Site #2). Overall study results are shown in below (Table 1).

    IgG:
    Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
    IgM:
    Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%) Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
    Overall (either IgG+ or IgM+):
    Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%~99.0%)

    Study 2: Independent Clinical Agreement Validation
    The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.
    All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
    For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below.

    Product Facts:
    Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
    Sample: Test can work with whole blood, plasma and serum samples.
    Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
    Shelf Life: Up to 24 months from manufacture date
    More information, such as the product insert, clinical trial results, and CE documentation is available at request
    Healthcare Provider Fact Sheet
    Recipient Fact Sheet
    More detailed results of ongoing clinical evaluations and test stability report for this Coronavirus test kit are available upon request.

    COVID-19 IgG/IgM Rapid Test Cassette 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.
    Interpretation of Results:

    Negative:
    The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
    IgM Positive:
    The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
    IgG Positive:
    The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
    IgG and IgM Positive:
    The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
    Invalid:
    Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

    Confirm BioSciences is gauging interest for IgG and IgM controls to be used with serology tests that detect IgG and IgM (COVID-19) antibodies. If you are interested in this opportunity, learn more here.

    Frequently Asked Questions
    Are these tests FDA approved?
    These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

    Confirm BioSciences is Healgen Scientific’s Largest Distributor in North America.

    Are these tests CLIA waived?
    Under the EUA our COVID-19 Rapid Test is certified for use in high- and moderate-complexity laboratories.

    To learn more, see the FDA’s guidelines.

    If you require additional guidance, please contact your Local State or County Health Agency to ask for about using devices under emergency use authorization.

    You can also review these links that might be helpful:

    Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
    CPT Codes for COVID 19 Tests
    How do I collect the blood sample?
    Please review the product insert regarding what type of blood sample will be appropriate to use in your test.

    Who can buy these tests?
    Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings.

    Is my test setting moderate- or high-complexity?
    CLIA (The Clinical Laboratory Improvement Amendments) has established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results. Under CLIA, a lab is any facility that tests human specimens for a health assessment or to diagnose, prevent, or treat disease. Facilities that meet this definition must obtain CLIA certification to operate legally.

    For more information, visit the CLIA Test Complexities page on CDC.gov or the CLIA Categorizations page on FDA.gov.

    If you need help obtaining moderate- or high-complexity status during the COVID-19 pandemic, please contact us to learn about available CLIA Lab Umbrella resources.

    CORONAVIRUS-COVID-19RapidTest

    $25.00 $16.50

    QUICK OVERVIEW

    FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
    (For Medical Professional Use Only)

    FDA Emergency Use Authorized Coronavirus (COVID-19) Instant Test Kits
    FDA Emergency Use Authorization (EUA)
    Rapid results within 10 minutes
    Small sample size
    Sold in packs of 25
    Shelf life of up to 24 months from manufacture date
    Test to be performed in a CLIA moderate- or high-complexity setting *
    Verification of use case prior to shipping is mandatory
    Interested in IgG and IgM Controls? Inquire here for availability
    Watch this video to see how the COVID-19 Rapid Test works →
    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.

    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 detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Act, 21 U.S.C. $360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    * The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.

    To request more information about our Rapid Coronavirus (Covid-19) test kit-such as the product insert or the CE documentation, please complete the form below.

    Sold in counts of 25, minimum of 25 units for all orders.

    First Name (required)
    Last Name (required)
    Email (required)
    Direct Phone Number (required)
    City (required)

    State (required)
    Business Name (required)
    Industry (required)

    Are you a medical professional or medical facility? (required)

    Desired quantity of test kits (required)

    Coronavirus Symptoms
    COVID-19 presents numerous symptoms that can range from mild to severe. Testing is the best solution to detect the virus that causes COVID-19.

    The most common symptoms include:

    Cough
    Fever or chills
    Shortness of breath or difficulty breathing
    Muscle or body aches
    Sore throat
    New loss of taste or smell
    Diarrhea
    Headache
    Fatigue
    Nausea or vomiting
    Congestion or runny nose
    *these symptoms are very common and can occur in many conditions other than COVID-19

    If you are experiencing any of the above symptoms seek medical attention immediately to determine your exposure to Coronavirus.

    Can you have coronavirus symptoms without the fever?
    It is possible to be infected with the new coronavirus and have a cough or other symptoms with no fever, or a very low-grade one, especially in the first few days. Keep in mind that it is also possible to have COVID-19 with minimal or even no symptoms at all. (John Hopkins Medicine)

    Confirm BioSciences is proud to offer coronavirus testing solutions to help identify or rule out infection.

    COVID-19 IgG/IgM Rapid Test Cassette
    The Novel Coronavirus testing kit manufactured by Healgen Scientific LLC is conducted by using whole blood/serum/plasma and placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled “B.” Results should appear within 10 minutes and are invalid after 15 minutes. For more information, watch our video.

    Clinical Evaluation Results:
    Study 1: Healgen Clinical Agreement Validation
    The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2). At Site #1, 61 retrospective specimens and 4 prospective specimens were included in the study. At Site #2, 95 retrospective specimens and 31 prospective specimens were included in the study. The time from RT-PCR result to collection of specimens (plasma) ranged from 15-45 days (Site #1) and 0-38 days (Site #2). The time from collection of specimens (plasma) from each individual to testing ranged from 12-23 days (Site #1) and 3-29 days (Site #2). Overall study results are shown in below (Table 1).

    IgG:
    Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
    IgM:
    Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%) Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
    Overall (either IgG+ or IgM+):
    Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%~99.0%)

    Study 2: Independent Clinical Agreement Validation
    The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.
    All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
    For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below.

    Product Facts:
    Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
    Sample: Test can work with whole blood, plasma and serum samples.
    Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
    Shelf Life: Up to 24 months from manufacture date
    More information, such as the product insert, clinical trial results, and CE documentation is available at request
    Healthcare Provider Fact Sheet
    Recipient Fact Sheet
    More detailed results of ongoing clinical evaluations and test stability report for this Coronavirus test kit are available upon request.

    COVID-19 IgG/IgM Rapid Test Cassette 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.
    Interpretation of Results:

    Negative:
    The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
    IgM Positive:
    The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
    IgG Positive:
    The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
    IgG and IgM Positive:
    The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
    Invalid:
    Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

    Confirm BioSciences is gauging interest for IgG and IgM controls to be used with serology tests that detect IgG and IgM (COVID-19) antibodies. If you are interested in this opportunity, learn more here.

    Frequently Asked Questions
    Are these tests FDA approved?
    These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

    Confirm BioSciences is Healgen Scientific’s Largest Distributor in North America.

    Are these tests CLIA waived?
    Under the EUA our COVID-19 Rapid Test is certified for use in high- and moderate-complexity laboratories.

    To learn more, see the FDA’s guidelines.

    If you require additional guidance, please contact your Local State or County Health Agency to ask for about using devices under emergency use authorization.

    You can also review these links that might be helpful:

    Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
    CPT Codes for COVID 19 Tests
    How do I collect the blood sample?
    Please review the product insert regarding what type of blood sample will be appropriate to use in your test.

    Who can buy these tests?
    Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings.

    Is my test setting moderate- or high-complexity?
    CLIA (The Clinical Laboratory Improvement Amendments) has established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results. Under CLIA, a lab is any facility that tests human specimens for a health assessment or to diagnose, prevent, or treat disease. Facilities that meet this definition must obtain CLIA certification to operate legally.

    For more information, visit the CLIA Test Complexities page on CDC.gov or the CLIA Categorizations page on FDA.gov.

    If you need help obtaining moderate- or high-complexity status during the COVID-19 pandemic, please contact us to learn about available CLIA Lab Umbrella resources.

    Add to cart
  • Sale!

    DISPOSABLE FACE MASK 50 FACEMASKS PPE

    $49.00 $34.50
    50-PCS-Face-Mask-Medical-Surgical-Dental-Disposable-3-PLY-Earloop-Mouth-Cover/itm/KN95-Disposable-Protective-Face-Mask-CE-FDA-Certified-Safety-Respirator   Disposable Mouth Face Mask Dental Medical Surgical Dust Masks
    Easy to breathe through
    Meltblown Filter Layer
    Inner non-woven fabric
    Outher non-woven fabric
    Suitable for: home use, industrial use, medical use, first aid, and outdoor activities, and other daily use
    Ships within 24 Hours

    DISPOSABLE FACE MASK 50 FACEMASKS PPE

    $49.00 $34.50

    QUICK OVERVIEW

    50-PCS-Face-Mask-Medical-Surgical-Dental-Disposable-3-PLY-Earloop-Mouth-Cover/itm/KN95-Disposable-Protective-Face-Mask-CE-FDA-Certified-Safety-Respirator   Disposable Mouth Face Mask Dental Medical Surgical Dust Masks
    Easy to breathe through
    Meltblown Filter Layer
    Inner non-woven fabric
    Outher non-woven fabric
    Suitable for: home use, industrial use, medical use, first aid, and outdoor activities, and other daily use
    Ships within 24 Hours

    Add to cart
  • LATEX DISPOSABLE GLOVES KIT X 10 PAIRS PPE

    $8.50

    SHIPPING NO ARE INCLUDED
    Gloves Disposables latex
    Box x 50 pairs S,M,L

    LATEX DISPOSABLE GLOVES KIT X 10 PAIRS PPE

    $8.50

    QUICK OVERVIEW

    SHIPPING NO ARE INCLUDED
    Gloves Disposables latex
    Box x 50 pairs S,M,L

    Clear
    Select options