Understanding the Product
The HIV 1/2 test amounts to quick diagnostic tool for detecting the Human Immunodeficiency Virus, focusing on identifying antibodies to HIV types 1, 2, and Subtype O tainted by blood, serum, or plasma fr moduretic. so it stands specifically designed for utilization by healthcare professionals for in vitro diagnostic purposes es cozaar.
Important Information about HIV
- HIV, which stands for Human Immunodeficiency Virus, sparks off Acquired Immune Deficiency Syndrome (AIDS) en campral.
- The viral envelope comes from the host cell membrane and includes multiple viral glycoproteins.
- Each HIV particle contains two positive-sense RNA copies representative of its genome.
- HIV-1 has been detected present in cases involving AIDS, holders of aIDS-related conditions, and high-risk, yet asymptomatic individuals.
- HIV-1 includes Subtypes M and O. Subtype O, first identified in 1990 stemming from its distinct protein markers, has been found in locations like Cameroon, France, and Germany. Though less prevalent, HIV-2 primarily affects individuals from West Africa.
- HIV-1, HIV-2, and Subtype O all induce immune responses.
- a considerable force figure in common ways identify HIV exposure is by detecting antibodies veiled laden with blood, serum, or plasma.
- Despite their differing biological properties, serological activities, and genetic sequences, HIV-1, HIV-2, and Subtype O show significant antigenic cross-reactivity.
- Most HIV-2 positive sera can develop into detected with HIV-1 serological assays.
- The HIV 1/2/O Rapid Test Cassette is crafted to qualitatively identify antibodies to HIV types 1, 2, and/or Subtype O stained with blood, serum, or plasma.
Mechanism pertaining to Test
The test utilizes a qualitative, membrane-based immunoassay crafted to detect antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum, or plasma. The membrane is pre-coated with recombinant HIV antigens beneath the T1 and T2 test line regions. T1 contains HIV-1 and Subtype O antigens, whereas T2 has HIV-2 antigens. During testing, the specimen interacts with HIV antigen particles amidst the strip, migrating chromatographically by capillary action and then reacting with membrane-bound recombinant HIV antigen.
Usage Precautions
- The test incorporates recombinant HIV types 1, 2, and Subtype O antigens in both the particles plus the membrane coating.
- For professional in vitro diagnostic use only. use isn't apparent valid allowed after the expiry date.
- Avoid eating, drinking, or smoking in areas where specimens or test cassettes are handled.
- usage is lacking permitted test pouches whenever they appear damaged; discard accordingly.
- Treat all specimens as assuming they are potentially infectious and follow microbiological hazard precautions at all times.
- Protector gear as in laboratory coats, gloves, and eye protection is suggested for utilization when handling specimens.
- Dispose pertaining to used test kits in accordance with local regulations.
Storage and Stability Guidelines
- archive the kit in its sealed pouch beyond the surrounding temperature or refrigerated (2-30°C).
- Keep the test in its sealed pouch until usage; it will remain stable until the expiration date.
- don't pursue that freeze the kit.
- Use the kit before the expiration date.
- For long-term storage, keep specimens below -20°C.
- Blood collected via venipuncture ought to endure existence stored at 2-8°C if tested within two days; abandon that course in practice freeze this blood. Blood collected via fingerstick would be beneficial if used immediately.
- Temperature and humidity can impact results; specimens is required to persist brought to normal room climate before testing. Thaw and mix frozen specimens thoroughly before testing. Avoid repeated freezing and thawing cycles.
- The HIV 1/2/O Rapid Test Cassette is compatible with whole blood (from venipuncture or fingerstick), serum, or plasma.
- Tests it might occur conducted immediately after specimen collection. put a stop to that keep specimens maintained preserved held remaining left close to the usual regular indoor temperature conditions for large amounts of time. Serum and plasma has the capacity ongoing being stored at 2-8°C as much as three days.
- Ensure that shipped specimens comply with local transport regulations for etiologic agents.
Kit Usage Instructions
Allow the test kit, specimen, buffer, and/or controls to acclimate to common room temp (15-30°C) before initiating the test.
Bring the test pouch to household temperature before opening it. Remove and place the test cassette on a flat, clean surface.
For Serum or Plasma specimen:
Using the dropper, add 1 drop (approximately 25 μL) of serum or plasma as far just like specified area, followed by 1 drop (approximately 40 μL) of buffer. Start the timer as shown in relation unnear the illustration below.
For Whole Blood specimen:
Using the dropper, add 2 drops (approximately 50 μL) of whole life's liquid above the way in the interior of the bounds of the way unaiming designed in order to specified area, followed by 2 drops (approximately 80 μL) of buffer. Start the timer as shown during the illustration below.
Wait geared towards the colored line(s) to appear. Read results at 10 minutes; cease from doing interpret results after 20 minutes.
result interpretation
- given that the specimen contains antibodies to HIV-1 and/or Subtype O, or HIV-2, a colored line will appear among the test line region.
- if antibodies to both HIV-1 and/or Subtype O, and HIV-2 are present, two colored lines will appear encompassed situated neighboring the test line region, both indicating a positive result.
- If no antibodies are detected, no colored line will appear where the center involving the test region, signifying a negative result.
POSITIVE: Two or three distinct colored lines will appear, one part attached to midst inside the control region and one or two among the test region(s) (T1 and/or T2).
*Note: The intensity involving the test line color (T1 and T2) may dependent amidst the proportion of HIV antibodies encompassed in the vicinity of the sample. Any shade of color among the test line regions (T1 and/or T2) should happen considered labeled as positive result.
NEGATIVE: One colored line will appear enclosed inside the midst made up of control region with no visible lines encompassed in the vicinity of the test regions (T1 and T2).
INVALID: on the condition that the control line isn't visible appear, it indicates insufficient specimen volume or an incorrect procedure. Review the test instructions and repeat incorporating a new test cassette. whenever the issue persists, withdraw use and relate to your distributor.
Quality Control
A procedural control is included to verify that a colored line appears within scope belonging to control region, ensuring adequate specimen volume and proper membrane wicking. This internal control helps ensure sufficient specimen volume, proper membrane wicking, and correct procedural technique.
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