EBSALERT SARS-CoV-2 Antibody Rapid Test (COVID-19)
Coronavirus disease 2019 (COVID-19) is a respiratory infectious disease caused by the coronavirus SARS-CoV-2 and has been declared by WHO a global pandemic which has high infection and fatality rate. It is thought that the SARS-CoV-2 could transmit to humans through unknown vectors, and its transmission usually occurs by direct contact with the virus in respiratory secretions or infected droplets. The most common clinical features at onset of COVID-19 are respiratory symptoms, including the upper respiratory tract infection such as nasal congestion, runny nose, cough, fever, and gastrointestinal problems or loss of smell and taste. Currently, the test method of COVID-19 can be classified to virus detection and antibody detection. Compared with the conventional assay for antibody detection like Western Blot or ELISA with time—consuming procedures, the ALERT SARS-CoV-2 Antibody Rapid Test can provide a faster solution to determine if the antibodies to SARS-CoV-2 exist in the sample within 10 minutes.
ALERT SARS-CoV-2 Antibody Rapid Test is a lateral flow immunoassay to detect antibodies for SARS-CoV-2, the virus that causes COVID-19. This product can provide a faster solution to determine whether the antibody against SARS-CoV-2 exists in the human serum or plasma within 10 minutes.
EBS’s ALERT® SARS-CoV-2 Antibody Rapid Test has already received Emergency Manufacturing Authorization from Taiwan FDA and IVD certification from EU. Other certifications are in progress.
Get in touch to order your COVID-19 Rapid Test Cassettes:
Please note: Our COVID-19 rapid test is CE marked for professional use and is only available to business customers. We are not able to supply to private individuals at this moment.
E-mail: sales@ebs.com.tw
Tel: +886-2-2796-2656
Taiwan FDA EUA Approval, CE IVD Certificate
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SARS-CoV-2testcard(Figure1.)
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10tests
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Disposablecapillarytube(Figure2.)
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10tubes
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Desiccant
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10packs
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4
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Runningbuffer
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1 bottle
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Insert
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1pce
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Figure 1. The sample well marked “S” and the result window marked “C” and “T”
on the test card.
Figure 2. Immerse the open end of disposable capillary tube into the sample. The disposable capillary tube will spontaneously collect 10 pL of sample WITHOUT pressing the bulb end.
Specimen Collection, Preparation and Storage
Fresh serum or plasma (EDTA or Heparin): The tube of whole blood should be centrifuged for 5 minutes at 3000 rpm to remove the serum or plasma. If the specimen cannot be tested immediately, please preserve at 4°C for up to 7 days, and at -20°C for longer periods.
Check the integrity of package and components before testing. If the desiccant color turns to pink, this test card is not recommended to be used.
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Add 20μL of serum or plasma sample (collected twice by disposable capillary tube) into the sample well.
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Add 2 drops of running buffer into the sample well vertically.
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Test results will be ready in 10 minutes.
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(Note: To prevent the results be influenced by factor of time. Please interpret the results in 15 minutes.)
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Positive: A pink/red control line (C) and test (T) line appear in the result window indicate the presence of anti-SARS- CoV-2 antibodies in the sample.
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Negative: A pink/red control line (C) appears, but no pink/red test line (T) in the result window indicate the absence of anti-SARS-CoV-2 antibodies in the sample.
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Product Storage and Expiration
The kit should be stored at 2-30°C and used before the expiration date marked on the label. Reagents must be used up immediately after the test, and cannot be reused.
Warning
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For more information on potentially harmful ingredients, please refer to the manufacturer's Material Safety Data Sheet (MSDS).
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If the specimen is accidentally spilled, wipe it with 1% sodium perchlorate solution, diluted bleach (1:1 or 1:5 bleach to water mix) or 75% alcohol. Discard the used reagents and specimens in the biologically infectious waste area. It is recommended to sterilize at temperature of 121 °C under high pressure for 1 hour before disposal according to state and local laws.
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Wear protecfive clothing such as laboratory coats, disposable gloves and eye or face protection when handling samples and reagents.
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Do not use the test kit beyond the expirafion date marked on the label.
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Do not mix components from different lot numbers.
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Do not use the rapid test if the aluminum foil pouch is damaged or unsealed.
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The kit is intended for single use only.
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Read the product insert thoroughly before using this assay, and follow the instructions carefully. Failure to do so could lead to inaccurate test results.
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Use of this test kit with sample types other than those specifically approved for use with this rapid test may result in inaccurate test results.
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