COVID-19 Antibody Tests From Lumos

COV-ID From Lumos Diagnostics

99.4%

Sensitivity (PPA)

98.7%

Specificity (NPA)

10

Results In Minutes

Lumos COV-ID Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 will detect and differentiate IgM and IgG antibodies to SARS-CoV-2. In most people, IgM antibody is produced 5-10 days after disease onset in the acute infection stage. IgG antibody is produced secondary to IgM and indicates that the patient is at a later stage or previous infection.

Lumos COV-ID is intended for use by trained laboratory personnel and trained healthcare professionals.

Lumos COV-ID

25 COV-ID test kits per box.

Rapid, easy to use and is highly accurate.

COV-ID is stored at room temperature.

COV-ID is a Single combination test for IgG and IgM antibodies.

Lumos COV-ID gives results in just 10 minutes!

PRODUCT SPECS

Product Name – Lumos COV-ID IgM and IgG Dual Antibody Rapid Test Kit
SKU – SV04
Country of Manufacturer – China
Sample Type – Blood
Method of detection – Colloidal Gold
Sensitivity – 99.4%
Specificity – 98.7%
Conformity – 99.1%
Test Run Time (minutes) – 10-15 minutes
Mobile App – NA

PRODUCT DETAILS

Storage – Room temp
Shelf Life – 12 months from date of manufacturer
FDA EUA Status – Submitted
CE Status – CE Marked
Unit of issue – 25 tests per box
Availability – Ready to ship

COV-ID is intended for use by trained laboratory personnel and healthcare professionals.

Intended Use Statement

Intended Use Statement COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing. Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities. The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

Intended Use Statement COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing. Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities. The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

Intended Use Statement

Intended Use Statement COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing. Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities. The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

COV-ID The Diagnostic Kit (Colloidal Gold)

COV-ID The Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is available in specific global markets in compliance with country requirements.

It is CE marked and MHRA registered. This test has also been submitted for Health Canada Interim Order (IO) review as well as for review by ANVISA in Brazil.

It has been U.S. Food and Drug Administration (FDA) notified and submitted for FDA Emergency Use Authorization (EUA) review. For professional use only in qualified CLIA certified high complexity settings. Please contact Lumos for specific product details that align with U.S. FDA notification procedures.

COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is available in specific global markets in compliance with country requirements.

COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is CE marked and MHRA registered. This test has also been submitted for Health Canada Interim Order (IO) review as well as for review by ANVISA in Brazil.

COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 has been U.S. Food and Drug Administration (FDA) notified and submitted for FDA Emergency Use Authorization (EUA) review. For professional use only in qualified CLIA certified high complexity settings. Please contact Lumos for specific product details that align with U.S. FDA notification procedures.

COV-ID The Diagnostic Kit (Colloidal Gold)

COV-ID The Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is available in specific global markets in compliance with country requirements.

It is CE marked and MHRA registered. This test has also been submitted for Health Canada Interim Order (IO) review as well as for review by ANVISA in Brazil.

It has been U.S. Food and Drug Administration (FDA) notified and submitted for FDA Emergency Use Authorization (EUA) review. For professional use only in qualified CLIA certified high complexity settings. Please contact Lumos for specific product details that align with U.S. FDA notification procedures.

Intended Use Statement

 

Intended Use Statement COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing. Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities. The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

Intended Use Statement

Intended Use Statement COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing. Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities. The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

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