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Public call for data on diagnostic accuracy on nucleic acid amplification tests to detect resistance to TB and selected anti-TB agents

Nucleic acid amplification tests (NAATs) are promising technologies for rapid and accurate detection of TB and resistance to selected anti-TB agents. In December 2020, the World Health Organization (WHO) will convene a Guidelines Development Group (GDG) meeting to update its clinical guidelines on the use of NAAT for the detection of TB and resistance to selected anti-TB agents. From this meeting onward, the WHO will review relevant evidence on diagnostic accuracy for several NAAT assays.

The following NAAT assays or classes of NAAT assays will be discussed by GDG:

Centralized assays that present end-to-end solutions for TB detection and resistance to rifampicin and isoniazid (CDST): Index test 1);

Cartridge-based technology for isoniazid and second-line drug resistance detection (XDR cartridges): Index test 2);

Hybridization based technique for detection of pyrazinamide resistance (PZA LPA: Index test 3).

To enable this process, the WHO is issuing a public call for data, appealing to industry, researchers, national TB programs, and other agencies to provide appropriate evidence for the performance of these technologies. The data obtained will be necessary to facilitate the process of WHO policy updates.

Please send relevant data to ldr.policies@who.int by 1 August 2020. See below for more information about datasets, variables, and process parameters:

Annex 1: Data Requirements

Index test 1: Centralized assays that present end-to-end solutions to detect TB and resistance to rifampicin and isoniazid (CDDT platform).

Desirable characteristics of the test: (A) Sample preparation workflow included; (B) automated DNA extraction; (C) automated PCR preparation; (D) automatic result interpretation; (C) Capacity per run:) 24 tests; (D) Complete MDR-TB diagnosis time from sample: <12 hours; (E) Minimum desirable drug resistance detection: at least for INH and RIF.

Study Type: Clinical evaluation studies to confirm clinical performance on clinical samples.

Study population: Random sample of unselected patients with signs and symptoms of TB requiring evaluation for TB and / or resistance to isoniazid and rifampicin in sites of intended use.

reference standard: At a minimum, the same sputum culture and phenotypic DST results, wherever applicable (liquid or solid, with speculation) should be included for each result Index test 1. The use of a genotypic sequencing results where available would have an additional value to confirm the presence of mutations in addition to phenotypic GST results.

Index test 2: Cartridge-based technology for isoniazid and second-line drug resistance detection (XDR cartridges);

Desirable characteristics of the test: (A) automated real-time PCR; (B) automatic result interpretation; (B) Capacity per run 🙂 4 trials; (c) Time test results: <4 hours; (D) Minimum desirable drug resistance detection: at least for INH and FQ.

Study Type: (A) All major mutations cover isoniazid and second-line drugs, measuring the relevant sample, accuracy, and reproducibility of the test in contrived samples or panels for analysis. (B) Clinical evaluation studies to confirm clinical performance on clinical samples.

Study population: The intended use of patients with TB requires evaluation for resistance to isoniazid and second-line anti-TB agents in the sites of use.

reference standard: A minimum of one sputum phenotypic DST (liquid or solid, with speculative) must be included for each outcome. Index test 2. The use of a genotypic sequencing results where available would have an additional value to confirm the presence of mutations in addition to phenotypic GST results.

Index test 3: Hybridization-based technique (PZA LPA) to detect pyrazinamide resistance.

Desirable characteristics of the test: (A) automatic or manual hybridization method; (B) Automatic or manual result interpretation (C) Time of test results from the sample: <24 hours; (D) Minimum desirable drug resistance detection: at least for PZA.

Study Type: (A) pyrazinamide covering all major mutations in samples or panels of precision, precision and reproducibility of tests for measuring analytical samples; (B) clinical evaluation studies to confirm clinical performance on clinical samples;

Study population: Patients with resistance to TB and rifampicin require evaluation for resistance to pyrazinamide in sites of expected use;

reference standard: At a minimum, the results of a sputum phenotypic DST (liquid or solid, with speculation) should be included for each Index test 3. The use of a genotypic sequencing results where available would have an additional value to confirm the presence of mutations in addition to phenotypic GST results.

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