Specimen Data

FEND mission is to support the evaluation of early-stage TB diagnostics & novel diagnostic strategies in the context of existing clinical algorithms in TB endemic countries.

FEND for TB will perform proof-of-principle studies of novel diagnostics & strategies and provide feedback to diagnostic developers on the performance of the technologies and their most effective use in endemic settings.

Enrollment of FEND TB 1 Study Participants by Country

N = 4447

Enrollment of FEND TB 1 Study Participants by Protocol

N = 4447

Number of Banked Specimens

2954 Sputum
3224 Serum
6203 Urine
13481 Tongue Swabs
6378 PAXgene RNA Tubes
3224 Plasma
720 MTB Isolates

952 Sputum
1274 Tongue Swabs
329 MTB Isolates

1164 Serum
1026 Urine
1242 PAXgene RNA Tubes
371 Stools
2558 Plasma
39 MTB Isolates

Type of Technology

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57% Molecular

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39% Immunoassay

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4% Others

Assay Aim

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54% ID

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43% ID-AMR

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4% Host Response

Laboratory vs. Point-of-Care Classification

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50% Near Point of Care

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43% True Point of Care

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7% Lab Based

Primary Use Case
 

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89% Diagnostic/Confirmatory Test

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4% Monitoring (Treatment, Immune Status, Patient)

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4% Triage/Screening

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4% NA

Drug Resistance Target

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68% NA

^

25% Isoniazid, Rifampicin

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4% Fluoroquinolone, Amikacin, Ethambutol, Linezolid

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4% Isoniazid, Rifampicin, Fluoroquinolone, Bedaquiline, Linezolid

Validated Sample Types

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25% Urine

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21% Sputum

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14% Others

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7% Oral Swab

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7% Sputum, Sputum Sediment

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7% Plasma

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4% Sputum, Sputum Culture

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4% Whole Blood

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4% Finger Prick Blood, Whole Blood

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4% Sputum, Sputum Culture, Other

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4% Sputum, Other

Country of Manufacturer HQ

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29% United States

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21% China

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18% Republic of Korea

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18% India

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6% South Africa

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3% Germany

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3% France

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3% Canada

Region of Manufacturer HQ

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35% Western Pacific Region

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32% Region of the Americas

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21% South-East Asian Region

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6% European Region

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6% African Region

Updated October 2025