Covid-19 IgM IgG Rapid Test kit
Covid-19 Sars2-cov 2019 nCoV IgM IgG Rapid Test kit Result 10 minutes
Order MOQ 10K Tests
Price: Contact for quote, depending on order QTY
Production capacity: 500K kits/day
Packaging option 1 each kit is individually packed with 20 tests
20tests/kit box*68kit boxes = 1360Pcs/ctn
CTN Dimension: 66*36*56.5CM GW: 17KG
Packaging option 2 (saves space and hence shipping cost)
1000pcs/ctn individual kit boxes are included but not packed. Need clients to package on their own at destination
CTN Dimension: 66*36*28CM GW 10.3KG
As the virus spread in Wuhan, Chinese researchers developed a more rapid “point of care” screening test, – known as the COVID-19 IgG/IgM Rapid Test Kit, which detects antibodies that emerge some time after Covid-19 symptoms appear. A study in the peer-reviewed Journal of Medical Virology said the test could return results within 15 minutes, much faster than the current standard testing.
The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection. IgG appears about 14 days after infection. According to the March 16 FDA Guidance, antibody blood tests of this nature are “less complex” than the nucleic acid testing that the CDC and laboratories throughout the U.S. have been running since the start of this emergency.
Advantages of these types of tests, approved by the Chinese FDA and compliant with medical device regulations in Europe, include the following:
- Rapid results (under 15 minutes)
- Accurate: High sensitivity (~97%) and specificity (~92%)
- Well-validated on numerous cohorts in China
- CE approved and widely used in many European countries
- Whole blood testing likely remedies some false negatives inherent in respiratory swab samples
- Low cost
- Ease of use; no need for laboratory personnel, equipment or sample transport
- Can be easily mass produced to over 500,000 per day
Download Full Clinical Study Report clinical report for coronavirus_rapid_test_IgM_IgG
Instructions for Running a Test Covid-19 IgM IgG Rapid Test kit
- Allow the test cassette, specimen, buffer to equilibrate to room temperature (15-30°C) prior to testing.
- 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 immediately after opening the foil pouch.
- Transfer 10 μL of serum / plasma specimen or 20 μL (1 drop) of whole blood specimen to the sample well, then add about 80uL (about 2-3 drops) of buffer and start the timer.<
- Wait for the colored line(s) to appear.
- Read the result at 5-10 minutes.
- Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS Covid-19 IgM IgG Rapid Test kit
All test controls should be examined prior to interpretation of patient results. If the controls are not valid, the patient results cannot be interpreted.
INTERPRETATION OF RESULTS (Please refer to the illustration).
IgG POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test line region IgG indicates that COVID-19-IgG antibody was detected in the sample.
IgM POSITIVE: *The colored line in the control line region (C) appears and a colored line appears in test line region IgM indicates that COVID-19-IgM antibody was detected in the sample, and is indicative of primary COVID-19 infection.
IgG AND IgM POSITIVE: *The colored line in the control line region (C) appears and two-colored lines should appear in test line regions IgG and IgM. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies.
NEGATIVE: The colored line in the control line region (C) appears. No line appears in test line regions IgG or IgM.
INVALID: There is no line appear in the control line region (C).
IgM IgG vs RT-PCR Why use Covid-19 IgM IgG Rapid Test kit?
|COVID-19 IgM/IgG Ab Detection||RT-PCR Detection Methods|
|Principle||Detect antibodies in blood||Detect RNA in swabs|
|Sample type||Whole blood/serum/plasma||Throat swab|
|Sample collection||Whole blood collection is a routine operation, and serum is convenient for long-term storage.||Need to be collected by professionals, and must be transported to a professional laboratory for testing. Swabs cannot store for long time.|
Just need 20 µL blood or 10 µL serum/plasma and 2 drops of buffer.
Need nucleic acid extraction (40 min) and RT-PCR (60 min).
|Detection time||<15 min||>100 min|
|Positive detection rate||>95%
After window period of infection, the method has a high detection rate.
Due to the possibility of low nucleic acid content in the pharyngeal swab, improper sampling technique and possible problems in sample transport, etc., it is easy to cause false negative results.
|Clinical significance||IgM, as the earliest antibody, appears within 3-5 days after the virus enters human body and can be used for early screening of suspected cases. IgG is an antibody produced in the middle and late stages of infection, its positive indicates that the patient is in recovery or has a previous infection. IgG concentration in the convalescent period was 4 times or more higher than that in the acute period, which can be used as an indicator of convalescent period, and can be used for disease course monitoring and retrospective diagnosis of patients with COVID-19.||Just used for determine the presence of COVID-19.|
Precautions On The Handling Of Sample And Lab Waste of Covid-19 IgM IgG Rapid Test kit
- This kit does not contain any contagious materials, it is safe to ship/use under normal situation.
- All samples are contagious, please handle carefully according to local regulations, or following the guidelines of your local CDC or WHO.
- Used test cards shall be handled carefully as biolab waste, which shall be treated carefully according to guidelines of CDC/WHO.
Limitations Of This COVID-19 IgM IgG Test Kit
This kit is used as aiding tool for the testing of COVID-19, which shall be used in combination with RT-PCR/CT scanning. The results shall be determined by professionals. It is not a home use test. Before licensed by CDC, in the US, this kit can only used as research tool, which can not be used in clinical diagnosis of COVID-19.
FAQ for One Step SARS-CoV-2 IgG/IgM test
Does the One Step SARS-CoV-2 IgG/IgM test comply with the FDA?
Yes. The FDA has issued guidelines to developers of serology tests (IgG/IgM) . Due to the public health emergency, IgM/IgG rapid tests are not currently required to go through the FDA’s typical approval process, nor do they require an emergency Use Authorization (EUA). Serology tests are being treated differently by the FDA as opposed to the high complexity molecular tests. Compliant information and limitations consistent with FDA guidance is clearly stated on the package insert which accompany tests.
On March 16, 2020, FDA established a policy of not objecting to the development and distribution by commercial manufacturers of serology tests that identify antibodies to SARS-CoV-2, even if those tests do not have an EUA. FDA established this policy because “serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus.” FDA Guidance: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020), available at: https://www.fda.gov/media/135659/download
Our manufacturers have notified FDA that they have validated the “One Step SARS-CoV-2 (19-COVID) IgG/IgM Test” and that the test is being offered as set forth in FDA’s March 16, 2020 guidance. FDA has posted these notifications on its website.
Has the test been validated?
Yes. We understand that the manufacturer has validated the test in accordance with the recommendations in FDA’s recent guidance, titled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” which was issued on March 16, 2020. That guidance recommends that serology tests, like the Standard Q COVID-19 IgM/IgG Rapid Test, be validated with the following validation studies:
• Cross-reactivity/Analytical Specificity
• Class Specificity
• Clinical Agreement Study
How long do results take & what type of specimen?
Test kits include all supplies necessary for finger prick (whole blood). Results are visible directly on the test in 10 – 15 minutes. No additional equipment is required.
Can the test be used as a “sole basis” to diagnose or exclude SARS-CoV-2 (i.e., coronavirus)?
No. At this time, FDA’s guidance recommends that the results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status. Follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.
• Negative results do not rule out SARS-CoV-2 (COVID-19) infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or past or present infection with SARS virus (no. 6).
What is the clinical application of the test?
There is urgent need for rapid testing to quickly identify large numbers of previously infected patients, including asymptomatic carriers. This is important to reduce and prevent virus transmission, assure timely treatment of patients, and help return our citizens to the workforce.
These serology tests may help track the progression of the novel coronavirus, in individual patients or on a community level. They may also help health care professionals make more informed decisions regarding how to best care for their patients, in addition to other information, such as confirmatory tests, medical history, and symptoms.
The serology test information may be useful in instances where medical resources need to be rationed. Because serology tests measure antibodies, they can help assess the likelihood of past as well as present infection and are meant to be used as an aid to diagnosis in the mid- to later stages of the viral infection. Along with other information, such as the presence of symptoms, the tests may help health care professionals assess whether individuals (including health care workers) have recovered from the virus. Follow-up testing should be used for definitive diagnoses.
The serology tests also will help public health officials better understand how much of the U.S. population has been exposed. See Coronavirus Disease 2019 (COVID-19), https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html.
And perhaps most importantly, the One Step SARS-CoV-2 (COVID-19) IgG/IgM Test are particularly helpful because they can provide results within 10- 15 minutes, as distinguished from PCR tests, where it can take hours or days to get results. Rapid testing may help health care providers better protect patients and communities, and the test results, along with other medical information, may help health care professionals determine whether patients should be quarantined or whether they can return to normal activities.
Can I order tests?
Yes. Contact us through the website to initiate a discussion. MoQ is 1,000 test.
What are the Limitations of Use?
According to the FDA Policy for Diagnostic Tests for Coronavirus Disease, we are required to inform you of the following:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This test is not for the screening of donated blood.