Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 (Chinese origin)
- CE Certified
- ISO13485 Certified
- 95% accuracy rate.
- Result in 10-15 minutes.
Packed as 25 tests in a kit.
A kit contains 25x test devices, 1x sample diluent, 25x disposable pipettes, 1x insert
*Required but not provided: specimen collection containers, timer, centrifuge, alcohol cotton, sterile lancet
A box contains 30 kits. (30x25=750 tests)
Production & Handling: Available stock in Hong Kong.
Delivery: Approximately 1 week with DHL.
* For EU customers, we can make the customs clearance (in Bulgaria) if you wish. There will be additional charges for it.
HS Code: 3002150090
The Diagnostic Kit（Colloidal Gold）for IgG/IgM Antibody to SARS-CoV-2 is a rapid immunoassay for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 virus in Whole Blood /Serum / Plasma.
Coronaviruses belong to the Nidovirales、Coronaviridae and Coronavirus A large class of viruses found widely in nature. The 5 'end of the viral group has A methylated cap structure, and the 3' end has A poly (A) tail, the genome was 27-32kb long. It is the largest known RNA virus with the largest genome. Coronaviruses are divided into three genera: α,β, γ.α,β only the mammal pathogenic, γ is mainly lead to infections of the birds. CoV was also demonstrated to be transmitted mainly through direct contact with secretions or through aerosols and droplets, and it has been shown to be transmitted via the fecal-oral route. Coronaviruses are associated with a variety of diseases in humans and animals, causing diseases of the respiratory, digestive, and nervous systems in humans and animals.
SARS-CoV-2 belongs to the β coronavirus, which is enveloped, and the particles are round or elliptic, often pleomorphic, with a diameter of 60~140nm, and its genetic characteristics are significantly different from those of SARSr-CoV and MERS-CoV. The clinical manifestations are fever, fatigue, and other systemic symptoms, accompanied by dry cough, dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multi-organ failure, severe acid-base metabolic disorder, and even life-threatening.
The SARS-CoV-2 transmission has been identified primarily through respiratory droplets (sneezing, coughing, etc.) and contact transmission (nostril picking, eye rubbing, etc.).
The virus is sensitive to ultraviolet light and heat and can be effectively inactivated by 56℃ for 30 minutes or lipid solvents such as ethyl ether, 75% ethanol, chlorine-containing disinfectant, peroxyacetic acid, and chloroform.
The Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the Test region, anti-human IgM and IgG are coated. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgM or IgG in the test line region. If the specimen contains IgM or IgG antibodies to SARS-CoV-2, a colored line will appear in the test line region.
Therefore, if the specimen contains SARS-CoV-2 IgM antibodies, a colored line will appear in test line region M. If the specimen contains SARS-CoV-2 IgG antibodies, a colored line will appear in test line region G. If the specimen does not contain SARS-CoV-2 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred，Otherwise, the test result is invalid and the specimen must be retested with another device.
Reagent Preparation And Storage Instructions
All reagents are ready to use as supplied. The kit can be stored at room temperature (2°C -30°C, do not freeze!) for 12 months from the date of manufacture. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before use and should be used within 1 hour after opening the pouch( within the temperature of 2°C~30°C and humidity less than 80%); The test device is stable through the expiration date printed on the sealed pouch.
Specimen Collection And Storage
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
• Fingerstick Whole Blood
Wash the patient’s hand than allow it to dry. Massage the hand without touching the puncture. Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Gently rub the hand from the wrist to palm to finger to form a rounded drop of blood over the puncture site. Add the fingerstick whole blood specimen to the test device by using a capillary tube or hanging drops.
• Whole Blood
Collect blood specimens into a lavender, blue, or green top collection tube (containing EDTA, citrate, or heparin, respectively in Vacutainer®) by venipuncture.
Collect blood specimens into a lavender, blue, or green top collection tube (containing EDTA, citrate, or heparin, respectively in Vacutainer®) by venipuncture. Separate the plasma by centrifugation. Carefully withdraw the plasma into a new pre-labeled tube.
Collect blood specimens into a red top collection tube (containing no anticoagulants in Vacutainer®) by venipuncture. Allow the blood to clot. Separate the serum by centrifugation. Carefully withdraw the serum into a new pre-labeled tube.
Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if not tested immediately. Store specimens at 2°C-8°C for up to 5 days. The specimens should be frozen at -20°C for longer storage. Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis, or turbidity in order to avoid interference on result interpretation.
Before any test, the package Insert must be read thoroughly.
Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed.
• Visual inspection method:
Step 1: Place the test device on a clean, flat surface.
Step 2: Fill the capillary pipettes and transfer approximately 10 μL (or 1 drop) of fingerstick whole blood、serum、plasma or whole blood specimen to the specimen well of the test device, add 2 drops of Sample Diluent(about 60μL ~100μL) immediately into the sample well to assist the sample detection.
Step 3: The test results should be read in 10-15 minutes, and the results read after 15 minutes are invalid.