Specifications include, but are not limited to: 1. Contractor shall provide manual, single-use assay for detection of Helicobacter pylori antigen in fecal specimens ; 2. Contractor must meet analytical performance expectations during mandatory 30-day evaluation period. To include: (1) Validation panel (provided by company, if available). Expect ≥95% agreement. (2) Precision – Pos and Neg QC on Monday and Friday. Expect 100% precision. (3) Accuracy – 25 pos / 10 neg residual pt samples obtained from reference lab. Expect overall correlation ≥94% and PPA/sens and NPA/spec both ≥90%. If acceptance criteria are not met, lab may consider retesting discordant specimens, sending out for 3rd party adjudication, and/or expanding evaluation numbers. 3. Is a reader required? If required contractor shall provide at no charge. 4. Contractor shall provide reliable and timely shipments
