India’s First Targeted WGS test for TB
Directly from Sputum (No Culture required)
What is SPIT SEQ?
SPIT SEQ is a direct sputum based whole genome sequencing test for diagnosis and drug resistance testing in pulmonary tuberculosis. SPIT SEQ Mtb Test sequences the whole genome of Mycobacterium Tuberculosis (Mtb) from the sputum of patients suffering from tuberculosis.
TB Prevalence
- Worldwide, tuberculosis (TB) is the 13th leading causes of death and second leading cause from single infectious agent after COVID-19.
- The COVID-19 pandemic has reversed years of global progress in reducing the number of people who succumb to TB.
- The number of TB deaths increased in 2020 in most of the 30 high TB burden countries including India.
- As per WHO report in 2020 worldwide 5.8 million new TB cases were reported of which 1.8 million were from India.
- India account for almost 30% of total TB cases reported.
- According to WHO the number of deaths due TB have increased from 1.4million in 2019 to 1.51 million in 2020
Common Disorders
SPIT SEQ, MedGenome’s Mtb Test sequences the whole genome of Mycobacterium Tuberculosis (Mtb) from the sputum of patients suffering from tuberculosis.
Why do you need the test?
- Single test for diagnosis and drug resistance prediction – As the test includes sequencing the Mtb genome, it can diagnose the presence of Mtb as well as identify the mutations that are likely to cause drug resistance.
- Comprehensive Drug Panel – The existing molecular techniques have a limitation of covering only a few drugs. The whole genome sequencing of Mtb covers all drug resistance markers – reported as well as novel.
- Sample Requirement – The SPIT SEQ test uses direct sputum as the clinical sample for sequencing which renders the process simple and fast. The use of sputum eliminates the requirement of growing a culture and hence reduces the time delay in diagnosis.
- Multiple applications – Over and above diagnosis and drug resistance testing, the whole genome sequencing test for Mtb, due to its voluminous data availability, can be used for strain typing, epidemiology studies and disease surveillance.
When do you need to get tested?
A tuberculosis patient can undergo this test in order to diagnose as well as understand drug resistance and susceptibility in the causative microorganism- mycobacterium tuberculosis.
Why MedGenome?
MedGenome SPIT SEQ test is a direct sputum based test that offers multiple applications over conventional methods as follows:
| Parameter | Smear Microscopy | Culture Technique | Nucleic Acid Amplification Test (Xpert MTB/ CBNAAT) | Line Probe Assay | MedGenome Whole Genome Sequencing of MTB |
|---|---|---|---|---|---|
| Test application | Diagnosis | Diagnosis + Drug Resistance | Diagnosis + Drug Resistance | Diagnosis + Drug Resistance | Diagnosis + Drug Resistance |
| Strain Typing | No | Yes, but confirmation required | No | No | Yes |
| Specimen requirement | Direct Sputum | Culture | Direct Sputum | Culture | Direct Sputum |
| Drugs for which resistance testing can be done | NA | All (to be tested individually for each drug in a separate culture) | Click here | Click here | All (done in a single sequencing cycle) |
| Novel drug resistance mutations coverage | NA | NA (doesn’t check for markers, but action of the drug on grown TB culture) | No | No | Yes |
| Turn around time | 1-2 hours | 4-8 weeks for diagnosis and drug resistance test | 2 hours | 5 days (once the culture is grown)[4] | 15 working days |
| Sensitivity | 55% (among pulmonary tuberculosis)[2] | Less for Conventional Lowenstein Jensen- Solid Media High for Automated MGIT- Liquid Culture | 98% in smear positive cases 70% in smear negative cases[3] | 95.6% for RIF and INH 74.5% for OFX and AMK[4] | 100% (compared to Line Probe Assay as reference standard) |
| Specificity | 98% (among pulmonary tuberculosis)[2] | NA | NA | 90.1% for RIF and INH[4] 98.6% for OFX and AMK[4] | 98.04% (compared to Line Probe Assay as reference standard) |
FAQ
SPIT SEQ, the direct sputum based whole genome sequencing test for Mtb is validated with 100 samples
| Sensitivity | 100% compared to LPA as reference standard |
| Specificity | 98.04% compared to LPA as reference standard |
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