01
Research guidance, not a new test approval
WHO announced its evidence-generation guidance for new tuberculosis diagnostics on October 21. The publication page is dated October 20. These are separate dates for the announcement and document record; neither page supplies an exact publication hour.
The guidance addresses researchers, developers and funders. For someone reading a test headline, it helps separate the evidence a study supplies from a decision about whether a particular test should be used. This announcement is not an endorsement of a named product.
02
Accuracy and benefit answer different questions
WHO highlights evidence beyond accuracy, including outcomes important to people, feasibility, acceptability, equity and cost. A test can identify a target accurately without that finding alone showing that people receive better care. The path from a sample to an actionable result also matters.
First identify the target. WHO distinguishes tests for TB infection from tests used to diagnose TB disease. A headline that simply says “TB test” leaves an important question unanswered. Do not silently transfer a claim about one purpose to the other.
03
A hypothetical 90% result can be misunderstood
In diagnostic studies, sensitivity concerns people with the target condition; specificity concerns those without it. Neither is the proportion of positive results that are correct. The reference standard and study population matter when interpreting either estimate.
Here is an invented arithmetic example, not WHO data or the performance of any real TB test. Assume the target condition is known perfectly: 10 of 100 fictional people have it and 90 do not. Give the fictional test 90% sensitivity and 90% specificity.
| Test result | Condition present: 10 | Condition absent: 90 |
|---|---|---|
| Positive | 9 | 9 |
| Negative | 1 | 81 |
There are 18 positive results, but only nine are true positives: 9/18 = 50%. Changing the assumed proportion with the condition changes this calculation. This teaching example cannot estimate your own result or justify a testing decision.
Understand uncertainty around an estimate
Sources for this section: [3]
04
Five questions to keep beside a test headline
This is Kadomony's reading worksheet, not a WHO clinical checklist. Write a short answer—or “not reported”—for each question before sharing a striking accuracy claim:
- What job is the test meant to do? Write the target and where the result fits in care.
- Who and what were tested? Note the people, sample type and setting; identify who is missing.
- What is the comparison? Find the reference method and the denominators behind the percentages.
- What happens after the result? Separate measured patient outcomes from benefits that are only expected.
- Can people actually use it? Look for practical access, cost and follow-up information rather than assuming availability.
05
Keep the conclusion within the evidence
An unanswered worksheet item is a useful limit to record, not a reason to invent an answer or dismiss the entire study. Save the original link and the exact claim; a later report may address a different population or outcome.
Evidence limits: We read WHO's announcement and public publication overview, relevant existing FDA methods guidance and WHO's TB fact sheet. The full WHO PDF could not be accessed and was not reviewed. No diagnostic data were reanalysed and no independent clinical review is recorded. This report does not recommend a test or a change to care.
Sources
- WHO launches guidance on evidence generation for new TB diagnosticsWorld Health Organization · 2026Source accessed:
- Guidance on evidence generation on new tuberculosis diagnostics — official publication overviewWorld Health Organization · 2026Source accessed:
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests — sections 3–5U.S. Food and Drug Administration · 2007Source accessed:
- Tuberculosis — WHO fact sheetWorld Health Organization · 2026Source accessed:
Revision history
- Initial report prepared with automated assistance on October 23, 2026; the official public source pages were checked at 2026-10-23T00:06:03Z (UTC). The WHO announcement is dated October 21 and its publication overview October 20, at day precision. This report uses those accessible pages, sections 3–5 of FDA's existing diagnostic-test reporting guidance and the WHO TB fact sheet. The linked full WHO PDF was not accessed or reviewed; no diagnostic dataset was reanalysed. The numerical example is invented for teaching, not an observed test result or an estimate of personal risk. No independent clinical review is recorded.