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A Chronic Hepatitis B Diagnosed? What Does the Viral Load Test Results Indicate about Your HBV DNA?

Your doctor has most likely ordered multiple blood tests to determine the stage of your infection and whether your liver is being harmed by your chronic hepatitis B infection. All of these findings are taken into account by doctors when determining whether you require therapy and how frequently you should be checked.

We’ll look at how the HBV DNA or viral load test, one of the tests, can provide you with an early indication of your health and hepatitis B infection. A blood sample is used for the HBV DNA test, and the Polymerase Chain Reaction (PCR) method quickly produces HBV DNA fragments for measurement. International units per millilitre (IU/mL) are commonly used to quantify viral load nowadays. Still, it is measured in certain labs and areas using the previous unit of measurement, copies per millilitre (copies/mL).

A single international unit has roughly 5.6 copies, therefore 5,000 copies/mL is equivalent to 893 IU/mL if you ever need to convert copies into international units. In order to monitor your progress, don’t forget to maintain copies of your lab records on hand. A spreadsheet in Excel is quite useful.

Using the same lab for your test is a good idea because the sensitivity of HBV DNA tests can differ throughout labs. Less than 200 IU/mL is typically measured in labs. Everyone suffering from chronic hepatitis B should be informed that the viral load is deemed “undetectable” when it falls below the threshold.

Method Name: Real-Time Polymerase Chain Reaction (qPCR) based on TaqMan probe.

Reporting Name: HBV DNA Detect/Quant

Specimen Type: Plasma

Specimen Minimum Volume: 1.5 mL

Specimen Stability Information

Specimen TypeTemperatureTimeSpecial Container
PlasmaFrozen (preferred)84 days 
 Refrigerated6 days 

Clinical Information

Hepatitis B surface antigen (HBsAg) and hepatitis B core IgM antibody (anti-HBc IgM) are examples of HBV serologic markers that can be used to diagnose acute or chronic hepatitis B virus (HBV) infection. Molecular assays can also be used to detect HBV DNA. While serologic techniques are typically utilised to diagnose acute and chronic HBV infection, HBV DNA detection and quantification in serum can be helpful in the following ways:

  • Identify a few examples of early acute HBV infection (before HBsAg appears).
  • Identify active from inactive HBV infections
  • Track a patient’s reaction to anti-HBV treatment

Serum HBV DNA is a consistent indicator of active HBV replication. Within 30 days of infection, HBV DNA levels can be found; they typically peak during acute hepatitis and then progressively decline and vanish when the illness clears up on its own. Testing for HBV DNA in serum can be helpful in diagnosing acute HBV infection in cases of acute viral hepatitis when HBsAg test findings are unclear. This is because HBV DNA can be found around 21 days before HBsAg usually emerges in the blood.

Chronic HBV infection patients do not get rid of the virus and continue to test positive for HBsAg. These cases can be further divided into two groups: chronic inactive (nonreplicative) HBV (low or undetectable HBV DNA levels, HBeAg-negative) and chronic active (replicative) HBV (high HBV levels, hepatitis Be antigen [HBeAg]-positive). By distinguishing between active and inactive disease phases, serum HBV DNA levels can be used to assess the status of a chronic HBV infection. Compared to patients with an inactive HBV infection, those with a chronic active infection are more contagious and have a higher chance of developing a more serious liver condition. It is possible for a dormant chronic HBV infection to reactivate (becoming HBeAg-negative) with or without the serum HBeAg resurfacing. Among patients with HBeAg-negative illness, HBV DNA detection is the sole trustworthy indicator of active HBV.

For patients who test positive for HBeAg, the long-term suppression of viral replication with undetectable HBV DNA, HBe seroconversion, and elimination of HBeAg is the therapeutic aim of anti-HBV therapy. In individuals with HBeAg-negative illness, long-term viral suppression is usually the aim of therapy. Treatment with nucleoside/nucleotide analogues (e.g., lamivudine, adefovir, entecavir, tenofovir) can lead to the emergence of drug-resistant strains of HBV, which are characterised by the return of HBV DNA in serum after it had become undetectable or the increase of HBV DNA levels after a decline.

Reference Values

Undetected

  • The quantification range of this assay is 10 to 1,000,000,000 IU/mL (1.00 log to 9.00 log IU/mL).
  • An “Undetected” result indicates that hepatitis B virus (HBV) DNA was not detected in the serum specimen.
  • A result of “<10 IU/mL (<1.00 log IU/mL)” indicates that HBV DNA is detected, but the HBV DNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months.
  • A quantitative result expressed in IU/mL and log IU/mL indicates the degree of active HBV viral replication in the patient. Monitoring HBV DNA levels over time is important for assessing disease progression or monitoring a patient’s response to anti-HBV therapy.
  • A result of “>1,000,000,000 IU/mL (>9.00 log IU/mL)” indicates the presence of active HBV viral replication, and the HBV DNA level present cannot be quantified accurately above this upper limit of quantification of this assay.
  • An Inconclusive result with the comment “Submit a new specimen for testing if clinically indicated” indicates that inhibitory substances may be present in the specimen. When clinically indicated, collection and testing of a new specimen is recommended.

Clinical Reference

  1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15 Supply 15:35-44
  2. World Health Organization: Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. World Health Organization; March 2015. Accessed May 12, 2023. Available at www.who.int/publications/i/item/9789241549059
  3. Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH: AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63(1):261-283
  4. World Health Organization: Guidelines on hepatitis B and C testing. World Health Organization; February 2017. Accessed May 12, 2023. Available at www.who.int/publications/i/item/9789241549981

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Test Code Information

Test ID

Test Order Name

Order LOINC Value

HBVQN

HBV DNA Detect/Quant

3500

Acquired immunodeficiency syndrome (AIDS) is a chronic, potentially life-threatening condition caused by the Human Immunodeficiency Virus (HIV). HIV virus is of 2 types namely HIV 1 & HIV 2 of which HIV 2 is less transmissible & less likely to progress to AIDS. By damaging your immune system, HIV interferes with your body’s ability to fight infection and disease. It can spread through sexual contact or blood by sharing infected needles or from mother to child during pregnancy, childbirth, or breastfeeding. It may take years before HIV weakens your immune system & causes full-blown AIDS. Antiviral treatment has reduced the death rate due to AIDS. This is a quantitative test that gives the viral load of HIV 1 in your body. This is useful for monitoring response to treatment. In addition, it also indicates the immune status. An HIV positive individual with CD4 count of 200 or less is at risk of developing AIDS.

Why choose our HIV RNA viral Load testing services:

  • Accurate Quantification: Our state-of-the-art laboratory utilizes cutting-edge technology to provide precise measurements of HIV RNA in the bloodstream, ensuring accurate quantification for effective disease management.
  • Early Detection and Monitoring: Early detection of viral activity is crucial for timely intervention. Our RNA Viral Load Testing not only aids in the initial diagnosis of HIV but also plays a pivotal role in monitoring treatment efficacy over time.
  • Personalized treatment plans: We believe in personalized healthcare. Our detailed RNA Viral Load results contribute to the development of customized treatment plans, allowing healthcare providers to tailor interventions based on individual patient needs.
  • Risk Assessment for transmission: Our testing helps assess the risk of HIV transmission. Individuals with undetectable viral loads are less likely to transmit the virus, promoting responsible and informed decision-making.

How our services work:

  1. Sample Collection: Healthcare providers collect a blood sample from the patient through a simple and minimally invasive procedure.
  2. Advanced Laboratory Analysis: Our certified laboratories use cutting-edge PCR technology to analyze the viral load with a high level of sensitivity and specificity.
  3. Rapid and Secure Results: Results are delivered promptly to healthcare professionals through secure channels, ensuring quick decision-making and intervention.

Benefits of choosing Taqgen:

  • Clinical Excellence: Our team of skilled professionals is dedicated to delivering accurate and clinically relevant results to support healthcare decision-making.
  • Confidentiality and privacy: We prioritize patient confidentiality, employing stringent security measures to protect personal health information.
  • Commitment to Quality: Taqgen adheres to the highest standards of quality assurance, ensuring the reliability and accuracy of our HIV RNA Viral Load Testing services.

At Taqgen, we understand the critical role that precise diagnostics play in HIV care. Partner with us for cutting-edge technology, personalized solutions, and a commitment to improving the lives of those affected by HIV. Contact us today to learn more about our HIV RNA Viral Load Testing Services.

Shipping Guidelines

  1. Ship frozen plasma sample on dry ice only.
  2. If shipment will be delayed for more than 24 hours, freeze plasma at -20° C (up to 30 days) until shipment on dry ice.

Sample Required

Collection Container/Tube: EDTA Tube, 3 mL
Sample Type: Plasma
Sample Volume: 1.5 to 2 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer’s instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot plasma into EDTA tube.

Useful For

  • Detection and quantification of HIV-1 RNA in plasma of patients with HIV infection (ie, sero-positive)
  • Monitoring disease progression in chronic HIV infection
  • Monitoring response to anti-HIV therapy

Method Name: Real-Time Polymerase Chain Reaction (qPCR) based on TaqMan probe.
Reporting Name: HIV-1 RNA Detect/Quant
Specimen Type: Plasma
Specimen Minimum Volume: 1.5 mL

Specimen Stability Information

Specimen TypeTemperatureTimeSpecial Container
PlasmaFrozen (preferred)30 days 
 Refrigerated6 days 

Clinical Information
1. Viral load below 10,000 copies/ml is generally considered “low”.
2. An increase or decrease in viral load of more than three-fold may be considered significant.
3. Viral loads can vary considerably. Laboratory variations, acute illness, or recent vaccination can lead to elevations or variability in viral loads. However, variations of less than 0.5 log copies/ml. should not be considered as significant.
4. Values below 50 Copies/mL does not exclude the possibility of an infection. It may reflect a viral load below the detection limit of the assay.
5. HIV viral load values are known to be affected due to other clinical conditions, such as acute illness or recent vaccination. Hence viral load should be interpreted in conjunction with the clinical history, clinical status, and other diagnostic parameters.

Recommendation
1. Viral load is a monitoring test and hence should not be used for screening or diagnostic purposes.
2. Wide variation in viral load has been observed due to the following reasons:
a. Use of different technologies/platforms for follow-up testing: it is recommended to monitor patients using the same technology.
b. Non-adherence to specimen collection protocol: it is recommended to immediately freeze the serum/EDTA plasma after collection and separation.

Reference Values
Undetected

Interpretation

Copies/mlInterpretation
Target Not detectedSample provided does not contain HIV-1 RNA
Less than 50HIV-1 RNA Detected & below detection limit of the assay
50 to 50 millionHIV-1 RNA Detected within the linear range of the assay
>50 millionHIV-1 RNA Detected above the linear range of the assay

Methodology:
The quantification of HIV by Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) is TaqMan probe-based amplification of a specific region (LTR) of the HIV genome by the TaqGen System.

Note:
1. Specificity: HIV-1 Group M subtypes detected and quantified.
2. Sensitivity: Detection Limit of the assay is 50 Copies/ml.
3. Linear reporting range of the assay: 100-10 million copies/ml.
4. Conversion factor calculated for HIV-1 PCR: 1 IU/ml corresponds to approximately 0.5 copies/ml.

Limitations:
PCR is a highly sensitive technique; a common reason for paradoxical results is contamination during specimen collection of inappropriate specimen and inherent PCR inhibitors in the specimen.

Day(s) Performed:
Monday through Saturday

Report Available:
1 to 3 days

Test Code Information

Test ID

Test Order Name

Order  INR Value

HIVRQ

HIV-1 RNA Detect/Quant

3000

Empowering HIV management through Advances Proviral DNA testing

Welcome to Taqgen Diagnostic, a leading provider of HIV Proviral DNA Load Testing services. Our commitment to excellence and innovation in diagnostics ensures that individuals living with HIV receive accurate and actionable insights for effective disease management.

Why choose our HIV proviral DNA load testing services?

  • Comprehensive Viral Load Assessment: Our state-of-the-art Proviral DNA Load Testing goes beyond traditional methods, offering a comprehensive assessment of the proviral DNA in the bloodstream for a more detailed understanding of viral activity.
  • Early Detection and Treatment Optimization: Early detection of HIV is crucial for timely intervention. Our test not only aids in the initial diagnosis but also plays a pivotal role in optimizing treatment plans by providing continuous monitoring of proviral DNA levels.
  • Personalized Treatment Strategies: We believe in the power of personalized medicine. Our detailed Proviral DNA Load results contribute to the development of customized treatment plans, allowing healthcare providers to tailor interventions based on individual patient needs.
  • Resistance Analysis: Our testing includes a thorough analysis of potential resistance mutations, providing valuable information to guide healthcare professionals in choosing the most effective antiretroviral therapies.

How our Services Work

  1. Sample Collection: Healthcare providers collect a blood sample from the patient through a simple and minimally invasive procedure.
  2. Advanced Laboratory Analysis: Our certified laboratories utilize cutting-edge technology to analyze the proviral DNA load with a high level of sensitivity and precision.
  3. Timely Results Delivery: Results are delivered promptly to healthcare professionals through secure channels, ensuring quick decision-making and intervention.

Benefits of choosing Taqgen

  • Clinical Excellence: Our team of experienced professionals is dedicated to delivering accurate and clinically relevant results to support healthcare decision-making.
  • Confidentiality and Privacy: We prioritize patient confidentiality, implementing stringent security measures to protect personal health information.
  • Commitment to Quality: Taqgen adheres to the highest standards of quality assurance, ensuring the reliability and accuracy of our HIV Proviral DNA Load Testing services.

Empower your patients and healthcare providers with our advanced HIV Proviral DNA Load Testing services. Partner with Taqgen Diagnostics for cutting-edge diagnostics, personalized solutions, and a commitment to improving the lives of individuals affected by HIV. Contact us today to learn more.

Shipping Guidelines

  1. Ship frozen plasma sample on dry ice only.
  2. If shipment will be delayed for more than 24 hours, freeze plasma at -20°C (up to 30 days) until shipment on dry ice.

Sample Required

Collection Container/Tube: EDTA Tube, 3 mL Sample Type: Whole Blood Sample Volume: 1.5 to 2 mL whole blood Collection Instructions: 1. Blood collection with 21 gauge Syringes using BD vacutainer. 2. Aliquot whole blood into EDTA tube only.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood Ambient 2-3 days
Refrigerated 2 to 8 degrees 6 days

Useful For • Detection and quantification of HIV-1 DNA in blood 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, 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 the 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.

Copies/105 cells Interpretation
Not Detected Absence of HIV-1 DNA in patient’s Specimen
Detected Presence of HIV-1 DNA in patient’s Specimen
Less than 100 HIV-1 DNA Detected above the linear range of the assay
100 to 105 HIV-1 DNA Detected within the linear range of the 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 as 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 is contamination during specimen collection, inappropriate selection of specimen, presence of inherent PCR inhibitors, loss, or degradation of DNA.

Day(s) Performed: Monday through Saturday

Report Available: 1 to 3 days

Test Code Information

Test ID Test Order Name Order INR Value
HIVPQ HIV-1 DNA Detect/Quant 3500

Reference:
• DeSimone J, Pomerantz R. New methods for the detection of HIV. Clin Lab Med 22 (2002) 573–592.
• Beloukas A, Paraskevis D, Haida C, Sypsa V, Hatzakis A. Development and Assessment of a Multiplex Real-Time PCR Assay for Quantification of Human Immunodeficiency Virus Type 1 DNA. Journal of Clinical Microbiology. 2009;47(7):2194-2199.
• Oliveira M, Gianella S, Letendre S, Scheffler K, Kosakovsky Pond S, Smith D et al. Comparative Analysis of Cell-Associated HIV DNA Levels in Cerebrospinal Fluid and Peripheral Blood by Droplet Digital PCR. PLOS ONE. 2015;10(10):e0139510
• Saitoh A, Hsia K, Fenton T, Powell C, Christopherson C, Fletcher C et al. Persistence of Human Immunodeficiency Virus (HIV) Type 1 DNA in Peripheral Blood Despite Prolonged Suppression of Plasma HIV-1 RNA in Children. The Journal of Infectious Diseases. 2002;185(10):1409-1416.
• Desire N, Dehee A, Schneider V, Jacomet C, Goujon C, Girard P et al. Quantification of Human Immunodeficiency Virus Type 1 Proviral Load by a TaqMan Real-Time PCR Assay. Journal of Clinical Microbiology. 2001;39(4):1303-1310.

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

Specimen TypeTemperatureTimeSpecial Container
Dried Blood CardAmbient1 monthN/A
 Refrigerated 2 to 8 degrees6 monthN/A

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.

Copies/105 cellsInterpretation
Not DetectedAbsence of HIV-1 DNA in patient’s Specimen
DetectedPresence of HIV-1 DNA in patient’s Specimen
Less than 100HIV-1 DNA Detected above the linear range of the assay
100 to 105HIV-1 DNA Detected within the linear range of the 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

Test ID

Test Order Name

Order INR Value

HIVDH

HIV-1 DNA HOME ACCESS DETECT

3500

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