Our HIV home test kit is a convenient and accurate option for testing for HIV in the privacy of your own home. The kit is able to detect HIV-1 and HIV-2 antibodies, as well as type O antibodies, giving you a complete picture of your HIV status. The kit comes with everything you need, including a finger-prick blood test and a dropper for transferring a sample to the testing strip. Simply follow the instructions provided and wait for your results, which are available in just minutes. This test is highly accurate and provides reliable results, giving you the information you need to seek treatment and protect your health. Whether you are looking to take control of your sexual health or have been experiencing symptoms, our HIV home test kit is an effective option.
Parsagen In-Home Test is a certified HIV that allows you to test quickly and easily in the comfort of your own home. Accurate and reliable Oral swab
– no blood and pain-free Results in minutes
– No hazardous waste Includes
Product summary
- HIV 1 & 2 rapid test kit.
- Detects HIV 1 and HIV 2 antibodies.
- Meets WHO’s test standards.
- ISO 13485 & GMP certifications.
- 99.61% sensitivity, 99.8% specificity.
- For field & health care professional use.
- Tested by certified laboratories worldwide.
- Reduce HIV testing anxiety, with timely and painless results.
- Oral Fluid allows for easier results, an easy adjunct to a visit.
- No risk of infectious waste
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| HIV 1.2.O Cassette | Whole Blood/Serum/Plasma | PS-STD-024 | 25T |
KEY POINTS
Detection for: antibodies to HIV type 1, type 2 and Subtype O qualitatively in whole blood, Serum or plasma;
Specimen volume: Serum or Plasma specimen 25 μL;
Venipuncture or Fingerstick Whole Blood specimen 50μL;
Reading time: 10 minutes;
Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);
Relative specificity: 99.9% (95%CI*: 99.6%~100.0%);
Accuracy: 99.9% (95%CI*: 99.6%~100.0%).
INTRODUCTION
HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS.1 HIV-1 consists of Subtype M and Subtype O.
INTENDED USE
Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1, type 2 and subtype O in whole blood, serum or plasma to aid in the diagnosis of HIV infection.
TEST PROCEDURE
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 2 drops of buffer (approximately 80μL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80μL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is >99.9%, and the relative specificity is 99.9%.
| Method | ELISA | Total Result | ||
| Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) | Results | Positive | Negative | |
| Positive | 130 | 2 | 132 | |
| Negative | 0 | 1683 | 1683 | |
| Total Result | 130 | 1685 | 1815 | |
Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);
Relative specificity: 99.9% (95%CI*: 99.6%~100.0%);
Accuracy: 99.9% (95%CI*: 99.6%~100.0%).
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, Syphilis, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.
Interference studies
The following potentially interfering substances were added to HIV negative and positive specimens.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 2g/dL Albumin: 2 g/dL
Creatin: 200 mg/dL Hemoglobin 1.1g/dL
Bilirubin: 1g/dL Oxalic Acid: 600mg/dL
None of the substances at the concentration tested interfered in the assay.
LIMITATIONS
1. Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma)) is for in vitro diagnostic use only. The test should be used for the detection of HIV antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in HIV antibodies can be determined by this qualitative test.
2. Parsagen® HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of HIV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection.
3. For confirmation, further analysis of the specimens should be performed according to local health authorities’ guidelines, such as ELISA and/or Western Blot analysis.
4. As with all rapid test cassettes, all results must be interpreted together with other clinical information available to the physician.
5. This test is intended for initial checking purposes only. Results should not be used to determine the serotype of HIV infections.
6. Due to possible cross reactivity, the appearance of lines in both T1 and T2 does not necessarily indicate co-infection from HIV-1, HIV-2 and Subtype O.
7. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of HIV infection.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.