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COVID-19 Test Kits
Type
Specimen
Form
Packaging
What are COVID-19 Test Kits?
A COVID-19 Test Kit is a medical diagnostic tool used to detect the SARS-CoV-2 virus or antibodies from an infection. Antigen and antibody testing kits allow for easy and efficient administration with minimal equipment. COVID-19 testing is an essential tool in identifying and managing the spread of the virus.
COVID-19 antigen test kits are able to detect the presence of viral antigens in nasopharyngeal or saliva specimens, which can assess a current viral infection. The COVID-19 antibody test is designed to detect the presence of antibodies in whole blood, serum, or plasma specimens, which helps provide information about past infections.
Both of these COVID-19 tests utilize immunochromatographic technology. These lateral flow tests offer quick results, typically within 15 minutes.
AdvaCare Pharma is the supplier of COVID-19 Test Kits, which are manufactured in ISO and CE-certified facilities in India, China, and the USA. Every facility is regularly inspected to ensure they are compliant with healthcare standards for quality and safety.
Product Specifications
Type
COVID-19 Antibody Test Kit is a rapid, qualitative diagnostic test for detecting the antibodies to SAR-CoV-2. This style of test is a cassette, which is a plastic box with a thin test strip enclosed. The test strip utilizes the immunochromatographic assay principle. There is a designated area for a whole blood/serum/plasma sample to be applied.
The cassette features an area in which the two lines that correspond to the specific antigens for IgM and IgG and a control line can be viewed.
COVID-19 Antigen Test Kit is a rapid test for the qualitative assessment of the presence of the SAR-CoV-2 antigen. This test has been designed to be used with a specimen obtained by nasopharyngeal swab or saliva swab.
The cassette is a plastic box that includes a thin test strip inside. The strip utilizes the immunochromatographic assay principle, which contains specific antibodies that bind to any antigen within the nasopharyngeal or saliva sample.
Specimen
Whole Blood/Serum/Plasma sample is used for this test. Collect blood using standard venipuncture (2 drops) or fingerstick (50 μL) techniques. This specimen is transferred (after centrifugation, in the case of serum/plasma samples) with a capillary tube or dropper to the assigned area of the cassette, where a drop of the corresponding buffer dilution will be added immediately afterward to proceed with the test.
Nasopharyngeal Swab is used to take a sample of cells from the nasopharynx, upper nose, and throat. The swab is packaged in a sterile blister pack. The long, thin part of the swab is made of plastic.
The tip of the nasopharyngeal swab is used to absorb a sample of fluid from the nasopharynx. Immediately after collection, the tip should be placed in a buffer dilution to proceed with the test.
Saliva Swab is used to take a small sample of cells from the saliva inside of the mouth. The saliva swab comes packaged in a sterile blister pack. The long, thin part of the swab is made of plastic.
The saliva swab tip is used to absorb a sample of fluid from the tongue and the inside of both cheeks. Immediately after collection, the tip should be placed in a buffer dilution to proceed with the test.
Form
Cassette consists of a plastic box with a test strip inside. It has an area for sample placement and a window, where a positive, negative, or invalid test result can be read.
The test strip inside of the cassette features an immunochromatographic assay, which can be used for the qualitative detection of antigens or antibodies due to the SAR-CoV-19 virus.
Why are we a leading COVID-19 Test Kits manufacturer?
AdvaCare Pharma is a globally recognized manufacturer of COVID-19 Test Kits, which are a part of the AccuQuik™ branded line of diagnostic detection devices. A STED dossier accompanies each of our products, providing confidence to our partners and distributors that our medical instruments meet the highest standards. AdvaCare Pharma is a CE and ISO-compliant manufacturer of both COVID-19 antigen test kits and COVID-19 antibody test kits.
For over two decades, AdvaCare Pharma has focused on delivering high-quality, cost-effective pharmaceutical products and market-specific solutions for our global partners. We stand out from other large-scale global distribution companies by implementing a vested supplier-distributor relationship. Currently, our distribution network spans 65 markets worldwide.
Uses
How should a COVID-19 Test Kit be used?
The way COVID-19 Test Kits are used varies depending on the type of test being conducted:
- For antibody testing, a small sample of whole blood, plasma, or serum is required.
- Conversely, rapid antigen testing necessitates the collection of nasopharyngeal or saliva samples.
- Once the sample is collected, it is applied to the designated area on the test kit, along with a buffer solution as specified in the instructions.
- Users must wait for the prescribed duration, allowing the test to develop.
- After the designated time elapses, results should be interpreted according to the guidelines included with the kit.
How should COVID-19 Test Kits be disposed of?
Proper disposal of COVID-19 Test Kits is required to prevent the spread of infection and maintain safety standards. Used test kits should be carefully placed inside a biohazard bag to contain any potentially infectious materials. Once secured, the bag is tightly sealed to prevent leakage.
The exterior of the bag is also thoroughly disinfected to eliminate any surface contamination. The biohazard bag containing the used test kits is then disposed of in a designated medical waste container, following established protocols for the disposal of biohazardous materials.
How should COVID-19 Test Kits be stored?
To guarantee the integrity and efficacy of COVID-19 Test Kits, adequate storage conditions must be maintained. Unused test kits should be stored in a dry environment within the recommended temperature range of 2-30°C (36-86°F). Avoid exposure to extreme temperatures, excessive moisture, or direct sunlight, as these factors can compromise the accuracy and reliability of the tests.
Store test kits away from potential contaminants and incompatible substances to prevent cross-contamination or degradation of test components. Implement regular monitoring of storage conditions to uphold the quality of the test kits and guarantee reliable results.
How are COVID-19 Test Kits utilized in hospital emergency departments?
In hospital emergency departments, COVID-19 Test Kits are a pivotal device in swiftly identifying potential cases of SARS-CoV-2 infection among patients presenting with respiratory distress or other indicative symptoms of COVID-19.
Emergency workers administer these kits following established protocols, conducting rapid antigen or antibody testing. This enables prompt triage, isolation, and treatment of suspected cases, contributing to successful patient care and infection prevention within the hospital setting.
How are COVID-19 Test Kits incorporated into workplace health and safety protocols?
COVID-19 Test Kits form an integral part of workplace health and safety protocols, aiding employers in safeguarding employees and maintaining a healthy work environment.
Employers implement routine testing procedures using these kits to screen employees for SARS-CoV-2 infection, particularly in industries or settings where physical distancing may be challenging.
FAQs
How does a COVID-19 Test Kit work?
The COVID-19 antibody test kit works by detecting the presence of antibodies that have been produced by the body in response to an infection with the SARS-CoV-2 virus, while the COVID-19 antigen test kit works by detecting certain proteins on the SARS-CoV-2 virus. Both tests utilize lateral flow testing, which is also known as a chromatographic immunoassay.
What is the difference between the COVID-19 Antibody Test Kit and COVID-19 Antigen Test Kit?
The antibody test detects the presence of antibodies within an individual's blood, which shows whether they have been previously infected with the virus. It is unable to detect the virus, and a positive result may not appear for several days after the initial infection.
The antigen test is able to detect the current presence of the virus in an individual's nasopharyngeal or saliva specimen. It is a rapid diagnostic test that can provide results in minutes, but there is a higher rate of false negatives compared to antibody testing for COVID-19.
Who should be tested with a COVID-19 Test Kit?
Both antibody and antigen testing can be used to test individuals who have symptoms of a COVID-19 infection (also called coronavirus disease) or who have been in close contact with another person who has a COVID-19 infection. Antigen testing is recommended within the first 5 to 7 days of infection.
Testing is also recommended for screening individuals who may be asymptomatic, particularly in settings like schools or workplaces where a potential outbreak may occur.
Should a nasopharyngeal swab or a saliva swab be used for the COVID-19 Antigen Test Kit?
Nasopharyngeal swabs typically provide more accurate results because they can collect specimens from deeper inside the respiratory tract but saliva swabs are less invasive and cause less discomfort. Saliva swabs are typically more convenient, as they can be performed without the assistance of a healthcare professional.
Are product specifications and technical documents accessible for your COVID-19 Antigen Test Kit?
Yes, product specifications and technical documents for our medical devices are available for product registration purposes or upon request for distributors and healthcare professionals.
What is the scope of medical devices that your company offers?
AdvaCare Pharma specializes in manufacturing a broad spectrum of more than 500 Class I and Class II medical devices, including surgical instruments, diagnostic devices, medical disposables, wound care products, and urological devices.
What are the shelf life and expiration dates for your medical devices?
The shelf life and expiration dates for our medical devices vary depending on the product and its storage conditions. Most Class I and Class II medical devices have a shelf life ranging from 3 to 5 years. Detailed information is provided with each product.
References
CDC Guidelines for COVID-19 Testing
The Centers for Disease Control and Prevention (CDC) provides comprehensive guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus (COVID-19). These guidelines cover the types of specimens recommended for different testing scenarios, including nasopharyngeal or oropharyngeal swabs for viral detection and serum for antibody testing. Adherence to these guidelines ensures the accuracy and reliability of COVID-19 tests.
Why AdvaCare Pharma?
As an industry leader, we are aware of our responsibility to provide affordable and sustainable solutions to improve healthcare worldwide.