HIV-1 HOME ACCESS DNA PCR

TaqGen® HIV DNA PCR HOME ACCESS TEST

A service that allows individuals to collect DNA samples in the comfort of their homes for HIV DNA Test, where your personal information is associated with a unique identifier rather than your name. This can provide a level of privacy while still allowing for accurate result delivery.

1. Order: Your Blood collection Card kit typically arrives within 3 to 5 days. Express shipping is available.
2. Spot: Follow kit instructions to spot blood in the DBS card (Dried Blood card) provided. Validate your DBS card using the barcode (Sample ID) so we know it belongs to you, no actual name of a person is required, since it is an anonymous testing and mail it back to our lab in the given package.
3. Report: In approximately one week, we will send you an email to let you know your reports are ready, confirm and reply to get your result online. Know what your DNA says about you.
4. Post Test counseling: Knowledgeable and trained counselors are available to interpret test results in a clear and understandable manner. They help individuals grasp the implications of their results, explaining both the positive and challenging aspects.

We try to get your results in the least possible time. As we appreciate that quick results mean less stress and anxiety. We can arrange your DNA test even when test participants live in different locations. We will ensure a quick, seamless, and timely process, working closely with our certified counselor and medical experts to provide you with your test results.

Once you have ordered your tests you will receive an email confirming your tests with the Sample ID and the location of your home. Mail your confirmation for the appropriate date of collection and once you receive the Blood collection card, follow the instruction and spot the blood and send them to our laboratory. Take your appointment for Pre and Post test counseling with our medical staff for absolutely free. Test results will be ready in 1 to 5 days. We will notify you when your results are all available. If your test shows a positive result and you need to speak to a doctor, just let us know, and we will arrange a discreet consultation at no further cost.

FAQS

1. Why HIV home-test?
   Stigma discourages people from seeking information and programs, for fear it will make others think they have HIV, are promiscuous or unfaithful. It also concerns about the attitudes of Lab technicians or medical officers and worries about what a positive result would mean are all barriers to us taking a test. But knowing your HIV status is the best way to keep yourself and other people healthy. So the privacy and control that home testing can provide should mean it’s a more attractive option for some people.
2. How does a TaqGen® HIV DNA PCR HOME ACCESS test work?
   This test involves the using of Dried blood spot (DBS card) specimens are collected by applying just 3 drops per circle of the card, drawn by lancet from the finger onto specially manufactured IVD DBS card. The blood is allowed to air dry for an hour. Spotted cards are then stored in low gas-permeability plastic bags with desiccant added to reduce humidity and may be kept at ambient temperature, even in tropical climates.
   Once the sample reaches the laboratory, technicians separate a small disc of saturated paper from the card to extract the Blood Genomic DNA and perform HIV-1 DNA Qualitative by using Taqman Realtime PCR method on IVD platform. The HIV DNA Realtime PCR test is 99% Sensitivity and 98% specificity.
3. Why Dried Blood Spot card?
   DBS sample can be obtained by just pricking the finger, so no trained lab technicians or phlebotomist required. It requires only a small amount of blood. It is easy to store and transport. No need for temperature control in transportation. It is Low biohazard. It is a widely used method of specimen collection for HIV-1 PCR testing around the world. It performs comparably with whole blood collection methods in terms of sensitivity and specificity for HIV using Realtime PCR assay. It facilitates wider accessibility to the testing service.

If you receive a positive result from your home test you should go to an HIV clinic as soon as possible for a confirmation test. Remember that it may take up to three months from the time of infection for traces of HIV to show up in an HIV test. The kit will provide you with more specific information about this ‘window period’.

Shipping Guidelines

1. Ship dried blood card (DBS) with shipping material given.
2. No cold condition required.

Sample Required
Collection card: Dried Blood card
Sample Type: Capillary blood from a fingertip.
Sample Volume: 2 drops of blood per circle of the card, at least 4 circles have to be spotted.

Collection Instructions:
1. Prick blood from a fingertip and blot it onto the card, at least 2 drops per circle. Dries the card and ship it.

Specimen Stability Information

Useful For
• Detection and quantification of HIV-1 DNA from Dried blood spot of patients with HIV infection (i.e., sero-positive).
• Monitoring disease progression in chronic HIV infection.
• Monitoring response to long-term ARV treatment and its effect on HIV latency.

Test Details:
Method: Quantitative Real-time PCR using Taqman technology.
Specificity: Assay is designed with specific primers and Taqman probe for in vitro quantification of all the genetic subtypes of HIV-1 group M against the LTR gene.
Target Selected: HIV-1 LTR, a highly conserved sequence among HIV-1 group M is selected for detection.
Sample: EDTA Whole Blood.
Limit of detection: 100 copies/ml.
Measuring Range: 100 – 100 Million copies/ml.
PCR system: CFX96™ Real-time PCR System-IVD (BIORAD).
Software: Bio-Rad CFX Manager IVD Edition 1.6.
Data Analysis Mode: PCR Quantification with standard curve.
Test Interpretation: HIV Proviral DNA Real-time PCR is done by using specific primers and sequence-specific Taqman Probe to conserved regions of HIV-1 Proviral DNA that exclude the HIV-2 infection. HIV-1 standard, Negative control, and Internal controls are run along with duplicates of patient samples to ensure more accurate and precise detection of Proviral HIV-1 DNA with least variation. “Detected” results indicate the presence of HIV-1 infection. Two consecutive positive HIV-1 proviral DNA test results are necessary for Diagnosis of HIV-1 infection in infants <2 years of age also for Patients. “NOT Detected” indicates either the absence of HIV-1 Proviral DNA in the patient’s Specimen or HIV-1 Proviral DNA level is below the detection limit of this assay.

Clinical Significance:
Proviral Human Immunodeficiency Virus Type-1 (HIV-1) proviral DNA is increasingly used to measure the HIV-1 cellular reservoirs, a helpful marker to evaluate the efficacy of antiretroviral therapeutic regimens in HIV-1–infected individuals. Furthermore, the proviral DNA load represents a specific marker for the early diagnosis of perinatal HIV-1 infection and might be predictive of HIV-1 disease progression independently of plasma HIV-1 RNA levels and CD4+ T-cell counts. The quantification indicates either the cell-Associated HIV DNA or HIV DNA+ cell or HIV Proviral Load. DNA levels were calculated and expressed copies per milliliter of whole blood. HIV-1 DNA levels in whole blood were measured at baseline (prior to initiation of study treatment) and at weeks 16, 32, 48, 64, 80, and 96.
Note: The linear dsDNA molecule is the precursor to the provirus, HIV infection of target cells generates a number of nonintegrated DNA species. These unintegrated HIV-1 DNA forms, which are linear or circularized, arise when viral dsDNA fails to integrate into the host genome, or linear unintegrated HIV-1 DNA may form. Therefore, aside from proviral DNA (HIV-1 dsDNA integrated into the host genome), several unintegrated forms also persist intracellularly. It is worth mentioning that cell-associated HIV-1 DNA can be found in both actively and latently infected cells. The new technique was developed to quantify proviral HIV-1 and all other forms of HIV DNA present intracellularly using a TaqMan real-time PCR assay.

Limitation of Assay:
The prime reason for paradoxical results are contamination during specimen collection, inappropriate selection of specimen, presence of an inherent PCR inhibitors, loss or degradation of DNA.
Day(s) Performed: Monday through Saturday
Report Available: 1 to 3 days

Test Code Information