Tuberculosis diagnostics/drug resistance dual-function detection reagents! Accurate diagnosis of tuberculosis is another weapon!

In October 2022, InnowaveDX MTB/RIF was registered and approved by the State Food and Drug Administration for marketing (National Equipment Approval 20223401367), a new product developed by Suzhou Chuanglan Biotechnology.
This is another blockbuster product in the field of tuberculosis after IP-10.
TB, which uses a real-time PCR method to realize the simultaneous detection of Mycobacterium tuberculosis complex and rifampicin resistance in the original sputum sample, and can complete the detection
of 24 samples within 3 hours using an automated protocol.

The approval of InnowaveDX MTB/RIF fills the gap of China's products for simultaneous tuberculosis diagnosis and rifampicin resistance detection in the original sputum sample, which can effectively improve the positive rate of tuberculosis etiological diagnosis, early detection of rifampicin resistance, faster detection of infectious sources in the early stage of tuberculosis, confirm tuberculosis, clarify tuberculosis drug resistance, guide better clinical implementation of treatment, and is expected to expand the new situation
of domestic tuberculosis detection.

China's tuberculosis etiology diagnosis has a long way to go!

Tuberculosis is one of the most widespread and deadly infectious diseases in the world, with a high prevalence and heavy social burden
.
According to the Global TB Report 2021, an estimated 10 million people fell ill with TB globally in 2020 and a total of 1.
5 million died from TB
.
China is the second highest burden of tuberculosis in the world, with about 840,000 new active tuberculosis patients in 20201
.
Rapid and accurate diagnosis of tuberculosis can help to inhibit the spread of tuberculosis bacteria, effectively treat tuberculosis, reduce the prevalence and curb drug resistance, which is the focus
of tuberculosis prevention and control research.

A positive test for Mycobacterium tuberculosis, including bacteriology and molecular biology, is the gold standard for TB diagnosis2
.
However, traditional laboratory etiological diagnostic methods for tuberculosis (sputum smear, sputum culture, traditional nucleic acid amplification) have a long cycle and cannot combine sensitivity and specificity
at the same time.
With the rapid development of molecular biology technology, the use of PCR technology to detect Mycobacterium tuberculosis pathogens and predict drug resistance has gradually been applied to clinical practice, especially Mycobacterium tuberculosis/rifampicin resistance real-time quantitative nucleic acid amplification detection technology (Xpert, Cepheid, Sunnyvale, CA), which can detect MTB and RIF resistance simultaneously within two and a half hours3
.
The WHO has approved the routine use of this test as an initial test in patients with symptoms of tuberculosis to speed up TB diagnosis
.
However, high hardware requirements and high detection costs limit the widespread use of Xpert, especially in developing countries with a high burden of TB4-5
.

WHO estimates that about 4.
1 million TB patients are currently undiagnosed or not officially reported to national health authorities, a significant increase
from 2.
9 million in 2019.
In 2020, the positive evidence rate of etiology of tuberculosis diagnosis in China was 55%, a significant increase compared with 2019 (only 45.
03% in 2019)6, mainly due to the improvement of sputum specimen quality, the gradual standardization of laboratory operations, and the use of
new technologies such as rapid liquid culture and molecular biology diagnosis 。 However, due to high hardware requirements and high detection costs, the new technology has not been widely promoted in China7, mainly relying on traditional detection methods, while traditional detection methods such as smear acid-fast staining have a low sensitivity of only 25.
68%, mycobacterial solid culture sensitivity is 51.
44% and time-consuming (6-8 weeks)8, therefore, there are large regional differences in the positive evidence rate of etiology of tuberculosis diagnosis in China, and the overall proportion is still lower than the global level (58%)1, and the misdiagnosis and missed diagnosis
。 Delays in diagnosis lead to delays in individualized treatment and transmission
of Mycobacterium tuberculosis.
Therefore, the diagnosis of tuberculosis etiology in China has a long way to go, and there is an urgent need for new diagnostic methods that are faster, more convenient, more sensitive and more cost-effective to assist the diagnosis of tuberculosis and guide treatment decisions
.

The situation of rifampicin drug resistance in China is grim

Rapid testing is urgently needed!

Multidrug-resistant tuberculosis (MDR-TB) and Rifampicin-resistant tuberculosis (RR-TB) remain serious problems
in global TB control 。 In 2020, a total of 132 222 MDR-or rifampicin-resistant TB patients were detected and notified globally, with 150359 people enrolled in treatment, only 32% of the five-year global target of 1.
5 million people, and a 15% decrease from the number of treatments in 20191.

TB, especially drug-resistant TB, is therefore a major challenge
to meeting the TB epidemic target on schedule.

In 2019, an estimated 484 000 patients with rifampicin-resistant TB were reported globally, with approximately 78% of MDR-TB patients9
.
China's rifampicin-resistant tuberculosis patients account for 12% of the world, second only to India
.
The literature shows that in the absence of rapid diagnosis of drug-resistant TB and rational application of second-line anti-TB therapy, the mortality rate of patients with drug-resistant rifampicin TB is close to 100%10
.
Therefore, early diagnosis of rifampicin resistance is essential
.
Phenotypic susceptibility is the gold standard for the diagnosis of drug resistance, but the detection cycle is long and biosafety requirements are high
.
In the 2021 edition of the "Technical Guidelines for the Prevention and Control of Tuberculosis in China", it is mentioned that "tuberculosis laboratories should screen all patients with positive etiology for drug resistance, and if molecular biology nucleic acid resistance detection technology is available, molecular biology drug resistance testing will be preferred"
.
The use of rapid molecular detection can quickly diagnose tuberculosis/drug-resistant tuberculosis, eliminate infectivity after effective treatment, effectively shorten the culture transformation time, and improve the treatment effect, which has important clinical value and is of great significance for reducing the incidence of tuberculosis and drug-resistant tuberculosis11
.

InnowaveDX MTB/RIF in raw sputum detection

Mycobacterium tuberculosis complex and rifampicin resistance,

Help accurate diagnosis of tuberculosis!

InnowaveDX MTB/RIF is an automated molecular diagnostic system that uses real-time PCR to detect IS6110 and rpoB target gene combinations, which can detect both Mycobacterium tuberculosis complex and rifampicin
resistance in raw sputum samples 。 The results of the clinical multicenter study involving more than 1000 patients showed that the positive coincidence rate between InnowaveDX MTB/RIF and Xpert for Mycobacterium tuberculosis was 99.
44% and 90.
09%, indicating that InnowaveDX MTB/RIF had a higher detection rate
for tuberculosis 。 Taking clinical diagnosis as the gold standard, the clinical sensitivity of InnowaveDX MTB/RIF detection for tuberculosis diagnosis is 57.
97%, so InnowaveDX MTB/RIF has good detection sensitivity for Mycobacterium tuberculosis complex, which can better improve the positive detection rate among tuberculosis patients, provide help for early diagnosis and treatment of tuberculosis, especially greatly improve the diagnosis
and treatment ability of drug-resistant tuberculosis 。 In addition, the drug resistance compliance rate and sensitivity compliance rate of InnowaveDX MTB/RIF test and Xpert test were above 97%.
The sensitivity consistency of rifampicin in traditional susceptibility tests was 93.
98%, and the consistency of rifampicin resistance was 99.
02%.

Therefore, InnowaveDX MTB/RIF has high sensitivity for the detection of Mycobacterium tuberculosis complex and rifampicin resistance, and has lower detection cost and higher detection throughput, which is more suitable for China's national conditions
.

The advantages of this product are as follows:

(1) Direct testing of raw sputum samples, while reporting Mycobacterium tuberculosis complex and rifampicin resistance results
.

(2) High sensitivity: Multicenter clinical trial data showed that InnowaveDX MTB/RIF had a high detection rate (58%)
of Mycobacterium tuberculosis complex among 1035 cases of pulmonary tuberculosis.
The total compliance rate of rifampicin-resistant mutant gene detection and Xpert reached 98.
85%; The overall compliance rate with the traditional susceptibility test rifampicin test was 96.
17%.

(3) High clinical specificity: In the samples of 180 non-tuberculosis cases, the clinical specificity was 100%.

(4) Higher throughput: 24 samples/batch, results
within 3 hours.
(5) Automated operation, raw samples do not need to be digested and centrifuged
.

(6) Freeze-drying process, room temperature transportation, simple operation, stable
product.
(7) Cover common mutation types of rifampicin (all mutation types required by national reference products can be detected).

Therefore, the InnowaveDX MTB/RIF test can be used as a sentinel test for TB diagnosis, especially for epidemiological initial screening of TB patients in low- and middle-income countries, increasing the proportion of patients with positive evidence of etiology for tuberculosis and rapid testing
for rifampicin resistance.

Tronlan Biotech has always adhered to the innovative research in the field of diagnosis of infectious diseases, and the combined detection of pathogens and drug resistance of InnowaveDX MTB/RIF Mycobacterium tuberculosis complex has opened up a new situation
for the diagnosis of tuberculosis.
Together with the previously marketed Mycobacterium tuberculosis specific cellular immunoassay IP-10.
TB, the two provide a one-stop overall solution for tuberculosis diagnosis, which can help the country achieve the 2035 prevention and control strategy proposed in the "13th Five-Year Plan" tuberculosis prevention and control plan strategy to contain and end the tuberculosis epidemic
.
In addition, Tronglan Biotech has also launched a number of innovative product solutions in many clinical applications such as respiratory infectious disease detection, gynecological & genital tract infection detection, fungal infection detection, etc.
, providing efficient, economical and rapid product solutions for clinical practice and promoting comprehensive and healthy development!