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HIV test kits on paper can be classified in several different ways. The primary classification is based on the types of tests conducted for the presence of human immunodeficiency virus in the body.
Diagnostic tests, viral load tests, resistance tests, and rapid tests, among others, are performed in specialized laboratories or diagnostic centers. In contrast, antigen/antibody tests, home tests, supplemental tests, and expedited tests can be performed at home, clinics, or non-laboratory settings.
Antigen/antibody tests are performed using blood, plasma, serum, or oral fluid samples to identify the presence of antigens and antibodies of the HIV virus. Therefore, a fingerprint blood sample is required. Some of these tests yield results quickly, within a few hours. Other advanced tests may require days.
Home test kits using oral tests and developed with a clear sensitivity and specificity design are easily available to clients. Still, they should perform them correctly to avoid mistakes. Even unaccounted user errors have often given accurate results.
Supplemental tests are performed to confirm positive results after an antigen/antibody test because they are cheap, cost-effective, and easy to use. Expedited tests are quick and give qualitative rapid results but are of low sensitivity and specificity compared to laboratory tests.
In this dynamic market, the need to be aware of what the end customer needs is imperative to ensure success.
Suppliers can consider the following points when choosing an HIV test kit paper that meets the needs of the target market:
Regulatory approvals and certifications
Suppliers should ensure that the tests selected have regulatory approvals in the market where they will be sold, like the FDA, CE marking, WHO pre-qualification. These approvals indicate that the tests meet the necessary accuracy and reliability standards.
Quality and performance
HIV test kits must be sensitive and specific. HIV test kit papers ideally should show high performance in terms of sensitivity and specificity for all the strains of the HIV virus. Check for the manufacturer's data on clinical evaluations or peer-reviewed studies demonstrating the kit performance.
Type of test
There are two basic types of tests: non-invasive and invasive. While non-invasive tests like finger prick are preferred, invasive tests like blood tests offer higher accuracy. Rapid tests (Antibody/Antigen) and home tests (oral fluid) are market-friendly.
Ease of use
The tests selected should hold user-friendliness and give clear and easy instructions. Lancets and control solutions should be provided, and the timing and result interpretation should be simple.
Supply and demand
When selecting suppliers, the quality of the raw materials and the availability of efficient lead times play important roles in this decision. Suppliers also consider the pricing structure for both bulk purchases and potential future pricing negotiations.
Market trends
This dynamic industry requires the need to stay on top of what the end consumers' needs, desires, and problems are to ensure that the suppliers can provide both the products and the solutions.
A fingerprint blood sample is the only sample required to run a test using HIV test paper. In a few minutes, it can yield rapid results of either positive or negative for the human immunodeficiency virus.
Some of the common features of the test paper for HIV include:
Some basic steps on how to use the test paper for HIV include:
There is no electronic and complex mechanical/technical device; hence, there is no hardware involved with the test paper for HIV. The integrity of the test paper must be maintained, and the following steps must be adhered to.
HIV test kits are used in a variety of business settings for healthcare industry uses like screening, diagnosis, and epidemiology, medical research, and insurance underwriting and employment checks. The rapid development of monoclonal antibodies and their application in diagnostics has revolutionized the industry, offering robust commercial opportunities.
Healthcare settings
In the healthcare industry, screening, education, and counseling drive demand. The need to confirm preliminary positive test findings is performed on a confirmatory basis. The labs require supplemental test kits that are low volume but high margin in the laboratory environment.
Diagnostic laboratories
The rapid need for diagnosis, especially as a result of the COVID 19 crisis, will enhance the demand for Immunoassay-based HIV test kits, including equipment, consumables, reagents, and supplies.
Government and public health agencies
In this dynamic marketplace, it is extremely important to be aware of the end consumer's needs in terms of product and solution to be able to ensure success. Government and public health agencies conduct large-scale testing campaigns, perform epidemiological surveillance, and respond to outbreaks, which drive demand. These organizations also seek innovative, cost-effective solutions that can be deployed quickly in various settings. Anticipated funding and policy decisions related to public health in general and HIV/AIDS in particular, including the USAID Procurement forecast, will again be key determinants of the demand and availability of the products.
Non-governmental organizations (NGOs)
NGOs undertake screening and counseling, deliver healthcare, and promote population education to mitigate the spread of HIV/AIDS. They demand quality test kits and supplies at the right time to complete their programs. Competitive pricing and ensuring solutions for Inventory control issues also encourage organizations to place orders.
It is essential to store the HIV STD test paper in a proper manner in order to keep its efficiency during the time of requirement. Certain important steps for storage include the following:
Cool and dry place
The test paper is mainly manufactured using sensitive chemicals that lose their effectiveness on exposure to elevated temperatures and moisture. For this reason, stores must keep them in a constantly cool and dry environment and away from direct sunlight and humidity.
Original packaging
The original packaging of the test paper is the ideal protective environment it is stored in. The pouches are said to contain desiccants that protect the test paper from moisture.
Keep capillary tubes Attached
The capillary bottles are used to transfer blood to the test paper, and they contain a segment of rubber tubing or test tubes. While collecting blood, the tube provides a vacuum to draw blood into the tube; hence, it must be maintained attached to avoid exposure to air, which may cause blood clot formation.
Avoid touching test paper
The HIV test paper is regarded as sensitive to fingerprints, so it must be touched with clean and gloved hands. Touching the test paper with naked hands may transfer oil, dirt, moisture, etc., that may affect its efficacy.
Time limits
Avoid using test papers beyond their labeled expiration dates; exposure to room air beyond the stipulated time limits may degrade the performance. Further, avoid using test papers that were stored improperly from opening to closing.
A1. Most HIV diagnostic tests, including the HIV test kit paper, are based on Enzyme Immunoassays (EIA) or Antigen tests. These are due to their high sensitivity and specificity for antibodies against the human immunodeficiency virus.
A2. HIV test paper is used to screen for incredible infection with the human immunodeficiency virus.
A3. The three basic methods for testing include antibody tests, antigen tests, and nucleic acid tests (NAT), which are the most common.
A4. 4th generation antigen/antibody combination tests are considered the latest.