Rapid HIV Test Device with Dual Malaria P V P F Test Detection
PRINCIPLE
The HIV 1/2/OTri‐lineHuman ImmunodeficiencyVirusRapid TestDevice / Strip (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV‐1,HIV‐2, and SubtypeO in whole blood, serum or plasma. The membrane is pre‐coated withrecombinantHIV antigens in the testlineregions,T1 and T2. The T1 testlineis pre‐coatedwithHIV‐1 and SubtypeO antigenand the T2 testline is pre‐coatedwithHIV‐2 antigen.During testing,the wholeblood, serum or plasma specimen reactswithHIV antigen coated particles in the test strip.The mixture then migrates upward on the membrane chromatographically by capillary actionand reactswith recombinantHIV antigen on the membrane in the testline region.If the specimen contains antibodies to HIV‐1 and/or SubtypeO, or HIV‐2, one colored linewill appear in the testline region; if the specimen contains antibodies to HIV‐1 and/or SubtypeO, and HIV‐2,two colored lineswill appear in the test line region.Bothindicate a positive result. If the specimen does not containHIV‐1, SubtypeO, and/orHIV‐2 antibodies, no colored linewill appear in the testline region indicating a negative result.To serve as a procedural control, a coloredlinewill always appear in the controlline region indicating that proper volume of specimen has been added and membranewickinghasoccurred.
Product Detail
Brand:QL
Specimens: : Whole Blood/Serum/Plasma（OR Serum/Plasma）
Reading time： Device：10 minutes Strip：15 minutes.
Pack：25 T
STORAGE: 2-30°C
KIT COMPONENTS（Device/Strip）
Test devices/strips
Droppers
Buffer
Package insert
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DIRECTIONS FOR USE
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HIV 1/2/O Tri‐line Human Immunodeficiency Virus Rapid Test Device
Allow the test device, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.
1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
For Serum, Plasma or Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80L) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40L) and start the timer.
For Fingerstick Whole Blood specimens: Fill the capillary tube and transfer approximately 50 L of fingerstick whole blood specimen to the specimen well (S) of the test device, then
add 1 drop of buffer (approximately 40L) and start the timer.
3. For hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50L) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer (approximately 40L) and start the timer.
4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 20 minutes
HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Strip
Allow the test strip, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.
1. Remove the test strip from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
For Serum, Plasma or Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of serum, plasma or venipuncture whole blood (approximately 80L) to the
“Specimen Pad” of the test strip, then add 1 drop of buffer (approximately 40L) and start the timer. For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 80L of fingerstick whole blood specimen to the “Specimen Pad” of the test strip, then add 1 drop of buffer (approximately 40L) and start the timer.
To use hanging drop: Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the “Specimen Pad” on the test strip, then add 1 drop of buffer (approximately 40L) and start the timer.
2.Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
HIV1&/orO Positive:* The coloredlinein the controlline region(C) appears and a colored line appears in testline region 1 (T1).The resultis positive for
HIV1&/orOinfection
HIV2 Positive: * The colored line in the controlline region (C) appears and a colored line appears in test line region 2 (T2).The resultis positive forHIV 2 infection
HIV 1&2 &/or O Positive: * The colored line in the control line region (C) appears and two colored lines should appear in testline regions 1 and 2 (T1 and T2). The color intensities of the lines do not have to match. The result is positiveforHIV1&2&/orO infection.
The colored line in the control line region (C) appears.No line appears in test lineregions1 or2 (T1orT2).
Controlline(C) fallsto appear.Insufficientbuffer volumeor incorrect procedural techniques are the most likely reasons for control line failure.
Review the procedure and repeatthe procedure with a new test strip. If the problem persists, discontinue using the test kit immediately and contact your localdistributor.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of colored in the test region (T) should be considered positive. -
The essence of our product resides in its dual-purpose design, which meticulously combines the detection of antibodies to HIV with the rapid diagnosis of malaria, specifically Plasmodium vivax (P.v.) and Plasmodium falciparum (P.f.), the two strains responsible for the majority of malaria cases worldwide. This seamless integration offers healthcare professionals a comprehensive tool, leveraging a qualitative, membrane-based immunoassay technology. The device operates effectively with whole blood, serum, or plasma samples, presenting a versatile solution for various clinical and field settings. Understanding the urgency and critical nature of accurately diagnosing these conditions, our product is engineered for reliability and efficiency. It empowers healthcare providers by delivering results swiftly, thereby facilitating prompt and appropriate interventions. The innovative design assures a straightforward and user-friendly testing process, ensuring accessibility even in resource-limited settings. This approach aligns with QL Biotech's dedication to enhancing global health outcomes through the provision of cutting-edge diagnostic solutions. Through our HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device/Strip with Malaria P V P F Test capabilities, we aim to contribute significantly to the battle against some of the most challenging infectious diseases facing humanity today.