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FAQs on Lab-On-TimeTM COVID-19 IgG/IgM Rapid Test
BASIC INFORMATION
Q: What are COVID-19 and SARS-CoV-2 Virus?
A: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2).
Q: What is the clinical classification of COVID-19?
A: The COVID-19 is clinically divided into 4 groups: mild, moderate, severe and critical. All 4 groups
can spread the virus and should be isolated from healthy people immediately and treated depending on the group.
Q: What product can we provide now?
A: BMT is a professional POCT reagent production company providing our COVID-19 IgG/IgM
Rapid Test. The test is available in two packaging options: professional packs (25 tests/kit with one bottle of buffer, and single use packs (each test is packaging with an alcohol swab, a lancet, and a buffer.
Q: What is the sample tested by this rapid test?
A: Whole Blood/Serum/Plasma as well as fingertip blood. A 20ul sample of blood or 10ul sample of Serum/ Plasma is all that is required.
Q: Is this a qualitative or quantitative test?
A: This is a rapid test for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 in whole blood, serum, or plasma.
Q: How is the test performed? Is it difficult to operate?
A: This product is easy to operate, does not require professional training, and has no site restrictions. It is suitable for rapid screening. Instructional videos are available to introduce the use of the product.
Q: How long does it take to interpret the results?
A: Results can be read at 10 minutes. Do not interpret results after 20 minutes.
Q: What are the storage conditions and expiration date of the product?
A: The tests should be stored in the sealed pouch either at room temperature or refrigerated (2-30 ℃ ). Under appropriate storage conditions, the test will be valid for two years after manufacture.
TECHNICAL INFORMATION
Q: What are IgG and IgM？
IgG antibodies are produced late after a SARS-CoV-2 infection, but remain for a long time, and disappear slowly. A positive IgG result in blood can be used as an indicator of SARS-CoV-2 infection and previous infection.
IgM antibodies are produced shortly after SARS-CoV-2 infection. Upon infection, they are produced rapidly, maintained for a short time, and disappear quickly.
Positive IgM results in blood can be used as an indicator of a recent SARS-CoV-2 infection.
Q: Can antibody tests be used as confirmation tests?
A: No. This test only indicates the presence of SARS-COV-2 antibodies in the specimen and should not be used as the sole criteria for the diagnosis of SARS-COV-2 and COVID-19. Positive results should be interpreted combined with other clinical information such as epidemiological history, clinical symptoms, imaging test results, molecular results and etc.3
Q: What is the appropriate time to detect IgG and IgM antibodies?
A: It was reported that after SARS-CoV-2 infection, IgM antibody can be detected in patient's blood after 3 - 5 days3 and IgG can be detected after 8 days. (1,2)
Q: Why is an IgG/IgM test important in diagnosing COVID-19?
A: This product has great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM and IgG combined assay has better utility and sensitivity
compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.
Q: What is a PCR test for COVID-19?
A: PCR stands for Polymerase Chain Reaction. It is a technique for rapidly producing many copies
of a fragment of DNA/RNA for diagnostic or research purposes. It is a very sensitive molecular testing method that directly detects viral RNA. The testing process is tedious, time-consuming and requires professional labs and experienced technicians due to the complexity of the test. PCR
was used at the beginning of the COVID-19 epidemic in China as the sole confirmatory diagnostic test. However, in a single PCR test, this virus was not detected in nearly 50% or more patients with upper respiratory tract infection (false negative). Serological test is helpful to remedy the defects of PCR detection method.
Q: Does a positive PCR test mean that the antibody test must be positive?
A: No. The PCR test result can be positive at the onset of symptoms if the virus is present in collected sample. However, the IgM/IgG development usually needs at least 3-5 days after primary infection, and some cases needs more days (even 14days). Without IgM or IgG in the blood the antibody test result will be negative.
Q: Have you had any clinical evaluation reports?
A: Yes, we completed clinical trials in three Chinese, Indian and European institutions.
Studies were performed in Hubei province, another study was conducted by the CDC and finally the Jiangsu province CDC. Evaluation reports are available upon request.
Q: How accurate is this test?
A: One clinical study included 446 specimens of IgG and 456 specimens of IgM.
IgG Results: Diagnostic Sensitivity:100.0%, Diagnostic Specificity: 99.5%, Accuracy: 99.6%.
IgM Results: Diagnostic Sensitivity: 91.8%, Diagnostic Specificity: 99.2%, Accuracy: 97.8%. Comparison studies are continuously being carried out, so more data will to be added soon.
Q: If the test results are positive, what measures should be taken?
A: If the patient has clinical symptoms, they should be isolated immediately and tested by PCR to confirm the diagnosis. If the patient has no clinical symptoms, their physical condition should be monitored and further PCR tests should be conducted. Repeated PCR test is recommended, if preliminary PCR results are negative.
Q: How does influenza compare with COVID-19?
Similarities:
1. They both cause respiratory diseases which present as a wide range of illness from asymptomatic or mild to severe disease and death.
2. They are both transmitted by contact, droplets and fomites.
Differences:
1. For COVID-19, data to date suggests that 80% of infections are mild or asymptomatic, 15% are severe infections requiring oxygen, and 5% are critical infections requiring ventilation. Severe and critical cases are significantly higher than what is observed for influenza infections.
2. Mortality for COVID-19 appears higher than for influenza, especially seasonal influenza.
Q: What is the diagnostic process of COVID-19?
A: First Screening Suspected COVID-19 Cases
Confirmed Diagnosis
A SARS-CoV-2 diagnosis is confirmed if the suspected cases also show one of the following etiological or serological evidence:
1.Positive result in Quantitative Real-time PCR detection of novel corona virus nucleic acid.
2.The sequence of the virus is highly homologues to that of SARS-CoV-2.
3.Specific IgM and IgG antibodies against SARS-CoV-2 test positive in the serum; IgG antibodies
specific to SARS-CoV-2 test positive after previous negative results or increased by more than 4 times in the recovery phase compared to the acute phase.
References:
1.Lee HK, Lee BH, Seok SH, et al. Production of specific antibodies against SAR Scoronavirus
nucleocapsid protein without cross reactivity with human coronaviruses 229E and OC43. J Vet Sci.
2010;11(2):165-167.
2. Wan ZY ZX, Yan XG IFA in testing specific antibody of SARS coronavirus. South China J Prev Med 2003;29(3):36-37.
3. Novel Coronavirus Pneumonia Diagnosis and Treatment Plan-Provisional 7th Edition backup.
4.Zhengtu Li1, Yongxiang Yi2, Xiaomei Luo, et al. Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis. Journal of Medical Virology.
ORCID iD: 0000-0001-8854-275X.