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What Is Tb Gold Test

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Is Latent Tb Contagious

What is Tuberculosis? How does TB gold test help detect tuberculosis?

Persons with latent TB infection are not infectious and cannot spread TB infection to others. Overall, without treatment, about 5 to 10% of infected persons will develop TB disease at some time in their lives. About half of those people who develop TB will do so within the first two years of infection.

Qft Is The Most Clinically Tested And Proven Igra

QuantiFERON-TB Gold is the most clinically tested and proven IGRA available . More than 30 million QFT tests have been sold across 130+ countries, including more than 7 million in 2015. Trust the only blood test for TB infection that offers:

  • The most accurate and reproducible results for TB infection
  • The confidence of more than 1200 clinical and scientific studies
  • Convenient and objective ELISA technology
  • Single visit testing

Question 1 What Is Quantiferon

The QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test that utilizes a peptide cocktail simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of interferon- by enzyme-linked immunosorbent assay is used to identify in vitroresponses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. QFT-Plus is an indirect test for M tuberculosis infection and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. This test does not differentiate between latent and active tuberculosis .1

CDC recommendations state that2,3

  • An interferon gamma release assay may be used in place of a tuberculin skin test in all situations in which CDC recommends TST as an aid in diagnosing adult M tuberculosis infections.

  • An IGRA is preferred for testing persons who have received Bacillus Calmette-Guérin as a vaccine or for cancer therapy.

  • An IGRA or a TST may be used without preference to test recent contacts of persons known or suspected to have active TB with special considerations for follow-up testing. IGRAs offer the possibility of detecting M tuberculosis infection with greater specificity than with a TST. If IGRAs are to be used in contact investigations, negative results obtained prior to 8 weeks after the end of exposure typically should be confirmed by repeat testing 8 to 10 weeks after the end of exposure.

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Understanding Results Ofquantiferon Tb Gold

Reference Range
Above 0.35 IU /mlPositive

*A Reference range is a set of values which helps the healthcare professional to interpret a medical test. It may vary with age, gender, and other factors. Reference ranges may also vary between labs, in value & units depending on instruments used and method of establishment of reference ranges

Tb Blood Test Vs Tb Skin Testing

What is QuantiFERON

Traditionally, TB screening has been done through a TB skin test, also known as a PPD test or a Mantoux test. To get a TB skin test, one needs to visit a medical office and receive a small injection of a substance known as a protein purified derivative in the forearm. After 48-96 hours, the forearm needs to be checked and measured by a medical provider to see if any swelling, or induration, has developed at the site of the injection. If a raised swelling above a certain size is noted on the second visit, a chest x-ray is required to make sure that tuberculosis is not present in the lungs. As a result, the TB skin test requires a minimum of two visits and possibly more if the TB skin test is read as positive.

As opposed to the TB skin test, the TB blood test is more convenient as it only requires one visit to a laboratory. During the lab visit, a simple, nearly painless blood draw is performed and the specimen is processed by the lab using specialized equipment. In contrast to the TB skin test, a second visit is not required for a TB blood test. And, because the QuantiFERON test uses sophisticated lab machinery instead of relying on manual skin measurements by a medical provider, this TB blood test is more accurate, particularly in borderline cases.

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Available Testing And Prevention

As with many illnesses, prevention is a great method in areas where this disease is very prevalent. The vaccine for TB is given to young children in countries with a high TB rate, such as Africa, South Asia and South America. The vaccine is not regularly used in the United States since the disease incidence rate is very low in this country. The lack of vaccination does create the need for testing and treatment when illness does occur. For those with confirmed TB, it is usually treated with a 6 month treatment plan of antibiotics.

Advantages Of The Quantiferon Tb Gold Include:

  • Not needing to return for the test results like the TB skin test which requires 2 visits
  • BCG vaccine will not cause a false positive in Quantiferon test as it sometimes does with a TB Skin test
  • Results are usually available in 3-5 business days
  • Can be used in all circumstances in which a TB Skin test is recommended

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An Alternative To The Tuberculin Skin Test

The QuantiFERON®-TB Gold In-Tube is a blood test for use as an aid in diagnosing Mycobacterium tuberculosis infection .3 The test is approved by the U.S. Food and Drug Administration for use with adult patients.

CDC Statement: “The greater specificity of the Quantiferon test and the requirement for only one visit are compelling advantages.”

What Are The Benefits Of Qft

Next generation TB testing with QuantiFERON TB Gold Plus

QFT-Plus is a highly accurate test with> 97% specificity for detection of TB infection.

QFT-Plus
One visit to the doctorTwo visits to the doctor
A small sample of blood is takenTuberculin is injected into the skin
Results are unaffected by the prior TB vaccinationResults may be affected by the BCG vaccine
Results determined in a laboratoryResults determined by subjective/visual assessment

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What If My Tb Blood Is Positive

A âpositiveâ TB blood test result means you probably have TB germs in your body. Most people with a positive TB blood test have latent TB infection. To be sure, your doctor will examine you and do a chest x-ray. You may need other tests to see if you have latent TB infection or active TB disease.

What Are The Advantages Of The Quantiferon

This blood test can measure active and latent TB infections, but only in adult patients. The TST is still considered the standard for children. Only one visit is required for this blood test instead of multiple visits with the TST, which saves everyone time and money.

There are some additional advantages that this blood test has over the TST as well.

Improved specificity.Instead of needing to visually judge a skin test, there is a set of baseline markers that test results can be compared against universally to determine if a TB infection is present.

There is less bias.Because the results of the blood test are measured universally, there is no local bias present in reading the results.

It cant be boosted.The TST will eventually become an inaccurate measurement of a TB infection because of what is known as the âboosterâ effect. After several skin tests, it is common for false positives to be read. The QuantiFERON-TB Gold blood test eliminates this effect completely.

It is accurate.Individuals who have received a BCG vaccination in the recent past will not receive accurate TST results. This blood test eliminates the inconvenience.

Although the accuracy of this blood test is often better than the TST, it is not appropriate for some individuals. Be sure to speak with your doctor about this TB test and if it could be right for you.

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Who Should Not Take The Quantiferon

Besides children, there are certain population groups that are not considered viable candidates for taking this blood test. Anyone who has an altered immune function fits into this category. This may be the result of an autoimmune disorder, an HIV infection, or people who are receiving immunosuppresive medications.

Certain clinical conditions may also alter the effectiveness of the results. This includes people who have a confirmed diagnosis of diabetes, renal failure, certain cancers and blood disorders, and silicosis.

Women who are pregnant are also not considered good candidates for this blood test.

The CDC, however, has approved the use of this blood test as a screening tool for virtually all individuals based on current data, even if the results from the test have not been studied. This is why it is important to speak with your provider about this specific blood test to see if it would be right for you.

Quantiferon Tb Gold Test Positive Treatment

Why Should Providers Choose QFT

The quantiFERON TB gold Test positive treatment includes the following steps

  • Special medication prescribed for the period of 6 to 9 months.
  • Use of gamma interferon therapy to monitor the treatment of tuberculosis.
  • The treatment is a long procedure owing to the slow growth of the M. Tuberculosis bacteria and also takes a lot of time to kill the bacteria.
  • Doctors can change the medication in course of the treatment in response to the emergence of drug resistant organisms.

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Tb Gold Test Positive

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In Vitro Tests For Exposure To Tuberculosis

The T-SPOT.TB and the QuantiFERON Gold test are two in vitro tests that detect memory cells and identify tuberculosis or latent tuberculosis. The former is being evaluated by the U.S. Food and Drug Administration for clinical use, and the latter test has been approved and is commercially available.

In the GFT-G test, blood lymphocytes are incubated with tuberculosis antigens not found in environmental tuberculosis species, PPD, or BCG vaccines. If an individual has memory cells to tuberculosis or a latent tuberculosis infection, T cells will produce INF-, which is measured in the laboratory using enzyme-linked immunosorbent assay .

In vitro tests have many advantages. The test can be completed in 1 day with no need for a second patient visit. It is more accurate than the skin test, and the interpretation of results is not affected by a readers bias or capability. Moreover, previous BCG immunizations do not influence the results. In vitro testing has great usefulness for tuberculosis surveillance of transients or large congregate populations such as military personnel or prisoners.

ClaudioSorino , … MicheleMondoni , in, 2022

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Diagnosis Of Latent Tb Infection Or Tb Disease

If a person is found to be infected with TB bacteria, other tests are needed to see if the person has TB disease. TB disease can be diagnosed by medical history, physical examination, chest x-ray, and other laboratory tests. TB disease is treated by taking several drugs as recommended by a health care provider.

If a person does not have TB disease, but has TB bacteria in the body, then latent TB infection is diagnosed. The decision about taking treatment for latent TB infection will be based on a persons chances of developing TB disease.

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10. What is the Quantiferon Gold Test?

Currently, QFT-G may be covered under your medical insurance plan. Talk with your insurance cover provider to find out whether this is the case. If you are looking for a new health insurance policy, consider browsing through hundreds for free at eHealthInsurance.com.

Medical rebates are available only if the person is immune-suppressed.

Advertising Disclosure: This content may include referral links. Please read our disclosure policy for more info.

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What Do I Do If I Have A Positive Qft

A positive result only indicates the likelihood of infection and does not mean you have active tuberculosis or that you are contagious. Active tuberculosis is diagnosed through a combination of laboratory tests , X-rays and other clinical evaluations. Your doctor will advise you on the next steps if you have a positive QFT-Plus result.

Active Vs Latent Tuberculosis

IGRAs cannot distinguish between latent infection and active tuberculosis disease, and should not be used as a sole method for diagnosis of active TB, which is a microbiological diagnosis. A positive IGRA result may not necessarily indicate TB infection, but can also be caused by infection with non-tuberculous mycobacteria. A negative IGRA does not rule out active TB disease a number of studies have shown that up to a quarter of patients with active TB have negative IGRA results.

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Qiagen’s New Generation Of Quantiferon Tb Test Gains Chinese Approval And Renewed Who Recommendation

QIAGEN N.V. today announced that its QuantiFERON tuberculosis testing solution has gained additional momentum with the approval of the fourth generation of this modern gold standard test in China and a new endorsement from the World Health Organization .

Among the recent developments:

  • China’s National Medical Products Administration has approved QuantiFERON-TB Gold Plus for TB diagnosis, including active TB infections. This builds on the regulatory approvals for QFT-Plus for latent TB diagnosis in the U.S. and other countries around the world, including CE-IVD marking. QFT-Plus is an important improvement over the previous version of QuantiFERON that was approved and used in China, offering even more accurate detection of infection, including in immunocompromised people. In China, all available IGRA tests including QFT-Plus are licensed to rule out active TB ? other countries also approve these tests to detect the latent form of the TB disease , in which people are infected, and have the potential to develop active disease. Since 2013, more than 1.5 million people in China have been tested for active TB infection using the proprietary QuantiFERON technology.

For more information, please visit www.qiagen.com

About QIAGEN

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Quantiferon Gold Tb Blood Test

QuantiFERON

The QuantiFERON Gold test, also known as a TB blood test, QuantiFERON test, QFT test and IGRA test, is a blood test that screens for tuberculosis . The QuantiFERON test was created to help identify people who have been exposed to a bacteria that causes tuberculosis known as Mycobacterium tuberculosis, or M. tuberculosis.

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Quantiferon Tb Gold Blood Test Results Meaning

For many years, the best way to determine if someone may have an active tuberculosis infection was to use a skin test. The tuberculin skin test is implanted just under the skin and then sits for a predetermined amount of time. The reaction to the TST is then judged by the care provider to determine if the result is positive, negative, or inconclusive. The QuantiFERON-TB Gold blood test takes some of the guesswork out of the tuberculosis screening process.

TB, when it isnt treated right away, can become a fatal disease. Even when it isnt fatal, tuberculosis can cause a lung infection, spread to the kidneys, and even affect the brain. Spread through droplets that come from the respiratory system, like with a sneeze, it can be spread from person to person quite easily. A definitive screening test is needed for certain professions because of close human contact and thats what this blood test can provide.

Quantiferon Tb Gold Test Overview

The QuantiFERON TB Gold In-Tube test is an indirect test for the M. tuberculosis infection which is based upon the measurement of the cell-mediated immune reaction to antigens simulating the mycobacterial proteins CFP-10, ESAT-6, and TB7.7. This combination of three mycobacterial proteins stimulates the patients T-cells in-vitro to release interferon-gamma, which then is measured using ELISA technology. This test detects infections produced by the Mycobacterium tuberculosis complex . The BCG strains and many other non-tuberculosis mycobacteria do not harbor ESAT-6, TB 7.7 and CFP-10 proteins therefore, persons either vaccinated with BCG or even infected with most environmental mycobacteria ought to test negative.

The QuantiFERON TB Gold In-Tube test is done by simply taking a small blood sample from the patient. To do this, a nurse will sterilize the arm, insert a needle to extract a vial of blood, then bandage the arm to ensure that there is no bleeding. The actual process of taking blood should only take about five minutes.

The test results can take seven to 10 days.

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What Is Latent Tb Infection

There are two phases of TB. Both phases can be treated with medicine.

When TB germs enter your body, they cause latent TB infection. Without treatment, latent TB infection can become active TB disease.

Phase 1 â Latent TB InfectionPhase 2 â Active TB Disease
TB germs are âasleepâ in your body. This phase can last for a very long time â even many years.TB germs are active and spreading. They are damaging tissue in your body.
You donât look or feel sick. Your chest x-ray is usually normal.You usually feel sick. Your doctor will do special tests to find where TB is harming your body.
You canât spread TB to other people.If the TB germs are in your lungs, you can spread TB to other people by coughing, sneezing, talking, or singing.
Usually treated by taking one medicine for 9 months.Treated by taking 3 or 4 TB medicines for at least 6 months.

Question 6 What Causes An Indeterminate Response

Quantiferon TB Testing

The 2 main causes of indeterminate results are1

  • Lack of incubating the samples properly

  • Insufficient or overly aggressive mixing of blood collection tubes

Other, less common, causes of indeterminate results are1

  • Presence of heterophile antibodies in the patient sample

  • Compromised immune status of the individual being tested

  • Intrinsic IFN- secretion

  • Lymphocytes responding indiscriminately

  • Lack of response to phytohemagglutinin

  • Storage of filled blood collection tubes outside the recommended temperature range

  • Compromised mitogen transport tubes

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