Amplified MTD test

The Amplified MTD test is part of Hologic's robust suite of molecular testing options designed to help diagnose microbial infectious diseases.

Amplified MTD specifically detects Mycobacterium tuberculosis (TB) rRNA directly and rapidly, while delivering the sensitivity of culture. The first FDA-approved direct test to help diagnose smear-positive and smear-negative specimens, the Amplified MTD test is highlighted by CDC diagnostic guidelines for TB.1

 

About

Approved for in vitro diagnostic use by the FDA in 1995, the Amplified MTD test is intended for use with specimens from patients who are showing signs and symptoms consistent with active pulmonary tuberculosis. The test is used in addition to acid fast bacillus (AFB) smear and culture. It is still important to perform culture due to the need for drug susceptibility information on isolates of Mycobacterium tuberculosis.

Features

The Amplified MTD test's single-tube format improves workflow and increases efficiency, providing results in as little as 2.5 to 3.5 hours.

Features and benefits include:

  • Our exclusive Transcription Mediated Amplification (TMA) technology, which optimizes sensitivity by producing >1 billion copies of RNA amplicon.
  • Amplicon detection by Hybridization Protection Assay (HPA) technology.
  • Reduced operating costs by eliminating the need for expensive thermal cycling equipment.
  • Decreased contamination by eliminating wash steps and the pipetting of amplicon.

Same-day diagnosis of TB with the Amplified MTD test better utilizes healthcare resources, improves efficiency and leads to optimal patient care through early identification and treatment initiation. 

Performance data

 

Table 1. MTD Laboratory Test Performance Using Patient Diagnosis as the Endpoint, Results from Smear-Positive Patients*

  Sensitivity Specificity PPV NPV Number of Patients
MTD 96.9% 100.0% 100.0% 87.5% 39
BACTEC 96.9% 100.0% 100.0% 87.5% 39
LJ 87.5% 100.0% 100.0% 63.6% 39
7H10/7H11 96.7% 100.0% 100.0% 87.5% 3

Table 2. MTD Laboratory Test Performance Using Patient Diagnosis as the Endpoint, Results from Smear-Negative Patients*

  Sensitivity Specificity PPV NPV Number of Patients
MTD 72.0% 99.3% 94.7% 95.3% 167
BACTEC 68.0% 100.0% 100.0% 94.7% 167
LJ 72.0% 100.0% 100.0% 95.1% 160
7H10/7H11 60.0% 100.0% 100.0% 93.4% 167

* Please see package insert for detailed information.

 

Regulatory

The Amplified MTD test was approved for in vitro diagnostic use by the FDA in 1995.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

Reference
  1. Centers for Disease Control and Prevention.  Update:  Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis. MMWR 2009; 58(01); 7-10.