SEQUENCE46 is now offering point-of-care rapid testing for anti-SARS-CoV-2 IgM and IgG antibodies.* This test is intended to screen patients for COVID-19 antibodies, as combining RNA and antibody tests can significantly raise the sensitivity for detecting COVID-19 in individuals. IgM antibodies appear in blood as soon as 3-5 days after infection for symptomatic patients and 7 days after infection for asymptomatic patients. IgG antibodies appear in blood within 2 weeks after infection. Over time, blood concentrations of both IgM and IgG decrease --IgM becomes undetectable but IgG typically remains elevated.
Overall Sensitivity: 90.11%
Overall Specificity: 98.46%
HOW TO ORDER
Contact us if you’re interested in purchasing kits for your practice.
Minimum 25 tests per order.
This test has been validated and FDA Emergency Use Authorization (EUA) has been granted.
This product is intended for professional use and not for home use.
Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A negative result may appear and not correlate with symptoms. A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.
More information can be found here. The testing protocol should be followed closely and it is imperative to use sufficient sample volume.
As of April 8, 2020, the World Health Organization (WHO) "recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available."
*Product may not be available in all markets.
FREQUENTLY ASKED QUESTIONS
Different news media have said that antibody tests are not accurate. How can I trust this test?
Dozens of antibody tests have hit the market since the start of the COVID-19 pandemic, and each test has its own sensitivity and specificity for detection of SARS-CoV-2 IgM and/or IgG antibodies. Based on the latest data (available in the product insert linked above), the test that SEQUENCE46 is distributing has an overall sensitivity of 90.11% and an overall specificity of 98.46%, with an overall accuracy of 95.31%. As a reminder, no antibody test should be used in isolation to diagnose or exclude a SARS-CoV-2 infection--test results should be considered in conjunction with other SARS-CoV-2 testing as well as any known symptoms.
Is this test manufactured in China? Different news media have indicated that tests from China are faulty.
Yes, the tests our laboratory is distributing were manufactured in China by Zhejiang Orient Gene Biotech Co., Ltd and imported into the U.S.A. by Healgen Scientific, a subsidiary of Orient Gene. While some tests manufactured and sold by companies in China were found to be faulty, Orient Gene’s tests were approved for shipment in late April.
What is the risk for a false positive test result?
As with any test, a false positive result is possible. The false positive rate of a test can be calculated as follows: (1 - specificity) * 100%. Note: the specificity should be in its decimal form in this formula.
What is the risk for a false negative test result?
As with any test, a false negative result is possible. The false negative rate of a test can be calculated as follows: (1 - sensitivity) * 100%. Note: the sensitivity should be in its decimal form in this formula.
How does timing affect test results?
IgM antibodies typically appear in an individual’s blood as soon as 3-5 days after infection for symptomatic patients and 7 days after infection for asymptomatic patients. IgG antibodies typically appear in an individual’s blood within 2 weeks after infection. Over time, blood concentrations of both IgM and IgG decrease--IgM becomes undetectable but IgG will remain elevated. Given this and based on existing research of COVID-19 antibody testing, waiting a sufficient length of time after symptom onset may increase the accuracy of the results.
Note: Kits can be stored at room temperature or refrigerated (2-30°C or 36-86°F) - DO NOT FREEZE. Do not use kits after the expiration date (24 months after manufacture date).