McKesson Consult FOBT Enhanced Readability 100 Tests – CLIA Waived is a professional fecal occult blood test designed for qualitative detection of hidden blood in stool specimens. The guaiac-impregnated test paper produces a visible blue color reaction when occult blood is detected, while the enhanced-readability design supports clear visual interpretation.
Each test slide provides two specimen application areas to support sampling from different portions of the stool specimen and incorporates positive and negative on-slide performance monitors. Results can be read in approximately 30 seconds to 1 minute after application of the developing solution. The CLIA Waived system is intended for professional in vitro diagnostic use as an aid in evaluating occult gastrointestinal bleeding and colorectal-screening workflows.
Key Features
| Enhanced Readability | Rapid Visual Results | CLIA Waived |
| Vivid color development supports straightforward interpretation | Results available in approximately 30 seconds to 1 minute | Suitable for applicable CLIA-waived testing environments |
| Guaiac Technology | Dual Sample Areas | On-Slide Controls |
| Detects occult blood through a guaiac-based color reaction | Two application sites support specimen sampling | Positive and negative monitors help verify slide and developer performance |
| Complete 100-Test Kit | Professional IVD Use | Latex Consideration |
| Includes slides, applicators, developer, and instructions | Designed for professional fecal occult blood testing | Not made with natural rubber latex |
Specifications
| Attribute | Details | Attribute | Details |
| Brand | McKesson Consult | Manufacturer | McKesson |
| MPN | 127-100ER | Product Type | Fecal Occult Blood Test Kit |
| Test Name | Fecal Occult Blood Test (FOBT) | Screening Category | Colorectal Cancer Screening |
| Technology | Guaiac | Test Method | Single Developer |
| Test Format | Test Card / Slide | Reading Type | Visual |
| Sample Type | Stool | Result Type | Qualitative |
| Time to Results | 30 Seconds to 1 Minute | Number of Tests | 100 |
| CLIA Classification | CLIA Waived | Specialty | Chemistry |
| On-Slide Controls | Positive and Negative | Sample Sites per Slide | 2 |
| Latex Indicator | Not Made with Natural Rubber Latex | Country of Origin | United States |
| Product Packaging | BX/100EA | Minimum Selling Unit | BX |
| BAA Compliant | No | TAA Compliant | Yes |
| UNSPSC | 41116120 | Intended Use | Professional In Vitro Diagnostic Use |
Kit Contents
| Component | Included |
| Test Slides | 100 Single Slides with On-Slide Controls |
| Applicators | 100 |
| FOBT Developing Solution | 2 Bottles |
| Product Instructions | Included |
Warnings
| Screening Aid Only | Dietary / Medication Interference | Specimen Collection |
| A positive result indicates occult blood and does not by itself diagnose colorectal cancer | Certain foods and medications can interfere with guaiac-based testing; follow current patient-preparation instructions | Collect and apply specimens exactly according to the instructions for use |
| Professional IVD Use | Developer Handling | Biological Safety |
| Intended for professional in vitro diagnostic testing | Avoid skin and eye contact and keep developing solution away from heat, sparks, and flame | Treat stool specimens and contaminated test materials as potentially infectious |
| Control Verification | Expiration Dating | Result Interpretation |
| Confirm expected performance of positive and negative monitors | Do not use expired test slides or developing solution | Evaluate positive or negative findings together with clinical history and appropriate follow-up testing |
The developing solution contains an alcohol/peroxide formulation and is classified as flammable and capable of causing serious eye irritation or damage, so appropriate handling precautions should be followed.
