SPIT SEQ - Whole Genome Sequencing

Revolutionising drug resistance diagnosis for tuberculosis

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What is a SPIT SEQ Test?

SPIT SEQ is a breakthrough diagnostic method that uses whole genome sequencing (WGS) to detect Mycobacterium tuberculosis complex directly from clinical samples. This NGS-based method accurately identifies drug-resistant strains of TB from both pulmonary (Sputum, BAL, etc) and extra-pulmonary (CSF, tissues, ascitic fluid, etc) samples. It detects drug resistance for over 20 drugs and allows detailed strain typing to ensure timely and precise treatment.

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Categorisation of Drugs Detected in SPIT SEQ

Drug Class	Drugs
First-line drugs		Rifampicin, Isoniazid, Pyrazinamide, Ethambutol.
Second-line drugs	Group A	Levofloxacin, Moxifloxacin, Bedaquiline.
	Group B	Clofazimine, Delamanid, Linezolid.
	Group C	Amikacin, Streptomycin, Ethionamide and Prothionamide.
	Other drugs	Kanamycin, Capreomycin, Cycloserine, Pretomanid, Rifabutin, Rifapentine.

Who May Benefit from the SPIT SEQ Test?

All patients diagnosed with tuberculosis, either by smear or GeneXpert.
Patients with suspected drug-resistant TB, including multidrug-resistant (MDR-TB), pre-extensively drug-resistant (Pre-XDR), extensively drug-resistant (XDR-TB), or rifampicin-resistant (RR-TB).

Specifications

Test Code: MGM1654, MGM1655.
Sample Type: Sputum, BAL, CSF, tissues, ascitic fluid, ocular fluid, other body fluids.
Sequencing Method: Next-generation sequencing (NGS) culture-free.
Sensitivity: 100% (compared to LPA as reference standard).
Specificity: 98.04% (compared to LPA as reference standard).
Drugs Tested: 20+
Strain Typing: Yes.
Turnaround Time: 14 working days.

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What MedGenome's SPIT SEQ Test Can Detect?

Drug-resistant Mycobacterium tuberculosis

Multidrug-Resistant TB (MDR-TB): MDR-TB is characterised by resistance to at least two of the most potent first-line anti-TB drugs: isoniazid and rifampicin. This form of TB poses significant treatment challenges and is associated with poorer health outcomes compared to drug-susceptible TB15.
Hr-TB: TB caused by M. tuberculosis strains resistant to isoniazid and susceptible to rifampicin.
Pre-extensively drug-resistant TB (pre-XDR-TB): It refers to TB caused by Mycobacterium tuberculosis strains that meet the criteria for MDR-TB and are also resistant to any fluoroquinolone or to at least one second-line injectable agent (e.g., amikacin, kanamycin, or capreomycin).
Extensively drug-resistant TB (XDR-TB): This form of TB is caused by M. tuberculosis strains that are resistant to MDR-TB agents (isoniazid and rifampicin) as well as to any fluoroquinolone and at least one of the three second-line injectable drugs.

Novel Drug Resistance Mutations Coverage

Resistance to all TB drugs, including first-line, second-line, and newer drugs.
Identification of rare drug-resistance mutations.
Newer drugs.
Novel mutation.

Key Highlights of MedGenome's SPIT SEQ

Quick and Precise Results

Detects DR-TB directly from both pulmonary and extra-pulmonary samples accurately and swiftly.

Comprehensive Drug Resistance Coverage

Predicts resistance for 20+ TB drugs, providing extensive diagnostic insights.

Fast Reporting

Receive detailed reports within 14 days, ensuring timely and personalized treatment initiation.

Superior Accuracy

Offers the most precise testing for first-line, second-line, and newer TB drugs, more economical than phenotype testing.

Peer-Reviewed Validation

Proven reliability through extensive peer-reviewed publications.
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Advanced Technology

Outperforms amplicon-based tests by sequencing the entire TB genome.

Detailed and Informative Reports

Provides comprehensive information on heteroresistance and TB strain lineage for optimal treatment strategies.

What is SPIT SEQ and how does it help detect Drug-Resistant Tuberculosis (DR-TB)?

Drug-resistant TB (DR-TB) arises when Mycobacterium tuberculosis becomes resistant to one or more TB medications, often due to incomplete or incorrect treatment. SPIT SEQ is a cutting-edge, NGS-based whole genome sequencing test that detects drug resistance directly from pulmonary (lungs) and extra-pulmonary (outside lungs) samples. Unlike traditional culture-based methods, it delivers rapid and accurate results enabling faster, targeted treatment. Drug-resistant tuberculosis (DR-TB) occurs when Mycobacterium tuberculosis complex, the bacteria that cause TB, develop resistance to one or more of the drugs used to treat the disease. This happens when TB treatment is mismanaged, such as incomplete or incorrect dosages, allowing the bacteria to evolve and survive.

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How is SPIT SEQ Different from Traditional DR-TB Tests?

Feature	SPIT SEQ	Traditional Drug Susceptibility Test (DST)
Test Method	Uses whole genome sequencing (WGS) directly from samples.	It often takes a long time, since the bacteria which cause TB grow very slowly.
Comprehensive Test Application	Identifies strain types and resistance to all drugs in a single test.	Detects resistance to only a few specific drugs.
Novel Drug Resistance Detection	Identifies both common and new resistance markers.	Detects only known resistance patterns.
Turnaround Time	Provides results in 10-14 days.	Takes 6-8 weeks for results.
Sensitivity	100% sensitivity and 98.04% specificity.	Sensitivity varies.
Cost	Less expensive than conventional drug susceptibility testing (DST), including 1st line and 2nd line drugs.	More expensive due to longer processing times and resource requirements.

MedGenome scientist conducting genetic testing and DNA test services in India

Why Choose SPIT SEQ for Diagnosis of DR-TB?

SPIT SEQ is an effective diagnostic test for DR-TB due to the following reasons:

Identifies resistance for over 20 drugs, including MDR TB, Pre-XDR, XDR cases, and ensure timely medical interventions.
Has a fast turnaround time, compared to older methods, helping to reduce complications and deaths.
Helps avoid giving the wrong drugs, saving healthcare time and resources.
Accurately identifies drug-resistant strains.

How Does SPIT SEQ Work for Diagnosing Drug-Resistant TB?

MedGenome clinician reviewing patient records to support genetic testing and DNA test in India

How is SPIT SEQ Done?

SPIT SEQ, the diagnostic test for drug-resistant tuberculosis (TB), involves next generation sequencing (NGS)

Step 1: The sample is collected from the patient in a sterile container.
Step 2: DNA is extracted from the sample and subjected to NGS.
Step 3:The DNA sequence obtained is computed and compared against the genomic TB database to identify drug resistance.

Who Should Consider SPIT SEQ?

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What Do SPIT SEQ Test Results Mean?

Positive or Negative Result: Shows if the TB bacteria are present.
Lineage Information: Tells the genetic type of the TB bacteria.
Drug Resistance Mutation Report: Lists which drugs the bacteria are resistant to, including:

- First-line drugs.
- Second-line drugs.
- Newer drugs.

Why Choose MedGenome for TB Diagnosis?

FAQs

How accurate is SPIT SEQ for diagnosing drug-resistant TB?
SPIT SEQ provides highly accurate results by detecting drug-resistant TB bacteria directly from patient samples. It checks for resistance to both first-line and second-line TB drugs, helping doctors make quick and informed treatment decisions, especially in difficult MDR TB cases.
What is the turnaround time for SPIT SEQ results?
SPIT SEQ gives results within 10-14 days, much faster than traditional culture-based tests. This quick response allows timely treatment and reduces delays in diagnosing drug-resistant TB.
Is SPIT SEQ effective for all strains of Mycobacterium tuberculosis?
Yes, SPIT SEQ is designed to detect all strains of Mycobacterium tuberculosis, including those causing both lung and extra-pulmonary TB. It provides a full picture of drug resistance, which is important in managing complicated TB cases.

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