Crescent Bioresearch urges research entities to check the endotoxin reports behind their materials and to verify results with a second laboratory, after a laboratory asked to confirm a result could not state the endotoxin value or threshold behind its pass.
ALBANY, N.Y., Oct. 30, 2026 -- Crescent Bioresearch, a supplier of laboratory compounds, is urging research entities to look closely at the certificates of analysis behind the materials they possess, and to verify their results with a second laboratory whenever the integrity of the reporting laboratory is unknown. The call follows an event in which a laboratory asked to confirm one of the company's results returned an endotoxin report that was nearly blank, and could not say what number its verdict rested on.
The event
Crescent Bioresearch sent a single sample to an outside laboratory to verify a result it had already received. The endotoxin report that came back was almost empty. It carried the lysate sensitivity of the test and, beside it, one word: pass. It did not state the measured endotoxin value, and it did not state the threshold the sample had been judged against.
At first the report raised little concern. To record the result properly, however, the company needed the two figures a pass is supposed to stand for: the value measured and the limit it was compared with. Crescent Bioresearch contacted the laboratory and asked for both. Even when asked directly, and in multiple ways, the laboratory was not able to provide a clear answer for the numerical endotoxin value or the threshold used.
A wider pattern
Crescent Bioresearch then reviewed endotoxin reports published by other suppliers of laboratory compounds. The same report, from the same laboratory, appeared across many of them: a pass beside a lysate sensitivity, with no measured value and no threshold. Those suppliers appear to have been relying on the reports without knowing what they left out.
A pass is a conclusion. It is meant to be the outcome of comparing a measured value with a stated limit. When neither figure can be produced on request, the pass cannot be checked, and a report that cannot be traced back to a measurement cannot be told apart from one that was never measured at all.
Why the numbers matter
An endotoxin result from the Limulus amebocyte lysate (LAL) test under USP <85>, the compendial Bacterial Endotoxins Test, rests on three figures. The lysate sensitivity is the lowest concentration the test can detect; it describes the test rather than the sample, and it is often mistaken for the result. The threshold is the limit the sample is judged against. The endotoxin value is the amount actually found. A report that prints only the sensitivity and the word pass shows that a test was named, not what it found. Crescent Bioresearch labels each of the three figures on its annotated endotoxin reports, so a reader can see where every number sits on the page and what it means.
Endotoxin, a lipopolysaccharide from the outer membrane of Gram-negative bacteria, survives the filtration steps that remove the bacteria themselves. In cell-culture and other laboratory models it can produce responses that are easily mistaken for the activity of the compound under study. A research entity that cannot see the endotoxin value cannot rule it out, and the data that follow rest on a figure no one has seen.
The four areas to check when validating a report
The company urges research entities to take four steps with every certificate they rely on.
First, confirm that the endotoxin report states the endotoxin value, the threshold and the test sensitivity, each with its unit, along with the determined pass or fail result. A pass without the value, or the threshold is an incomplete result. It must contain all four parameters to be proven as fact.
Second, check whether the reporting laboratory holds ISO/IEC 17025 accreditation, the international standard for the competence of testing laboratories, and whether the scope of that accreditation covers the test reported. Accreditation bodies such as A2LA, ANAB and PJLA publish searchable directories of the laboratories they accredit.
Third, where the reporting laboratory's testing integrity is unknown, or where a report raises questions, send a sample to an additional laboratory and compare the figures. This applies even when the first laboratory attests to its own results. Two independent figures that agree are a far stronger record than one figure that cannot be traced.
Fourth, confirm the report with the laboratory that issued it, by report number, so that the document on the page is the document the laboratory produced.
Accreditation and the testing chain
Third-party laboratories that do not hold accreditation are capable of running these tests. Many of them, however, work to a similar in-house procedure, and many of the tests offered to suppliers are sold by parent companies that contract the work to other laboratories, which run the assays themselves. Each step between the company that sells a test and the laboratory that performs it is a point where a figure can be lost, altered or never recorded.
For that reason, Crescent Bioresearch considers it essential that research entities establish that the information on a certificate is true, not only that a certificate exists. Accreditation is one assurance. Independent confirmation by a second laboratory is another. Together they give a research entity the firmest footing for the work that depends on the material.
Further information regarding the matter can be located at: Two Certificates, Only One Correct Answer | Crescent Discovery Series
ABOUT CRESCENT BIORESEARCH
Crescent Bioresearch is a supplier of laboratory compounds, founded around a framework of critical assessment. It works with research entities nationwide in pursuit of preserving the integrity of scientific research through its transparency approach. Follow the Crescent Discovery Series to dive into the latest breakthroughs and findings within prominent literature.
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