NOVEL TB TEST KIT that Detects Latent TB Infection

 

LATENT TB

A lump appears on the arm where the locally produced Cy-TB is injected just beneath the skin. Two to three days later, this is measured to determine whether the individual has the infection. According to Anonna Dutt, the bulge enlarges if they are disease carriers.

Mansukh Mandaviya, the Union Health Minister, has unveiled a "Made in India" TB skin test to be utilized in the disease control mission as India like other high disease burden countries strives to eliminate tuberculosis by 2025, five years ahead of the global sustainable development goal.

The test, which will be produced and commercialized by the Serum Institute of India under the name Cy-TB, is a slightly modified version of a century-old test that included injecting a protein extract of the tuberculosis bacteria under the skin to gauge the subject's response to the infection.

Why is the examination required? As a result of its capacity to identify latent tuberculosis infections. The national TB program now only focuses on identifying and treating people who have an active infection, or those who have already begun exhibiting symptoms. There are two ways to determine whether a patient has an active infection: by microscopy, in which the patient's sample is examined under a microscope, or by a test called a nucleic acid amplification, in which the genetic material of the pathogen is amplified and its segments are automatically matched by a machine to produce a positive result (just like an RT-PCR test for COVID-19). However, because these tests only examine a patient's sputum, they are unable to identify latent infections.

Nearly one-fourth of the world's population is thought to be carrying the TB bacterium in a latent state, but some of them may go on to become actively infected, particularly if their immune system is weakened by other diseases or medications. Despite the fact that those who have latent TB cannot transmit the disease, they serve as a reservoir for the bacterium to survive in humans.

Either a blood test or a skin test can be used to identify latent TB cases. The Mantoux test, a century-old skin test, has the drawback of also returning positive results for people who have taken the BCG tuberculosis vaccine. The test is worthless because the BCG vaccination is a component of India's standard childhood immunization program.

The new test measures the body's immune response to two of the antigens or infectious components of tuberculosis — EAST-6 and CFP10 — rather than utilizing a protein extract of the complete bacterium.

In order to do the test, the substance is injected just beneath the skin of the arm, creating a bump. Two to three days later, this is measured to determine whether the individual has the infection. If they are disease carriers, the hump enlarges.

The Statens Serum Institute in Denmark, with whom SII maintains collaboration, created the test. It does not need laboratory equipment and is far less expensive than latent TB blood tests. The population can be screened for TB using a skin test.

According to a clinical trial, it has the same level of safety as the Mantoux test but is more sensitive when used on members of the general public, family members of TB patients, and people who are at high risk of getting the disease. According to the topic expert committee under the top drug regulator of the country, the test would be offered to adults while the company conducts a study on those under the age of 18.

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