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AFP screening for open neural tube defects
A maternal AFP test is a noninvasive blood test that helps determine whether a pregnant woman is at increased risk of developing an open neural tube defect (NTD). It is most effective when performed between 16 and 18 weeks of gestation, but samples can be collected as early as 15 weeks or as late as 22.9 weeks. Although only a small percentage of women are screen positive, AFP screening does identify approximately one out of every 25 babies born with a defect.
A high AFP indicates the presence of a birth defect, like spina bifida. This level is usually 2.5 times higher than the “average” level. Conversely, a low AFP could indicate a condition such as Down syndrome or Edwards syndrome. For this reason, AFP screening is not recommended in women who have a high prepregnancy BMI. While AFP screening has its place, it is not recommended as the sole test.
False-positive rates
In order to reduce the rate of false-positive results, ontology pathologists need to employ strategies to minimize the risk of false-positive test results. ONTD3.5.7.9 explains technical limitations of ONTD methodology for certain intended uses. False-positive rates in Ontd are also low when compared to other tests in the same clinical laboratory.
Assays should contain two quality control samples, and three may be required for licensure. A laboratory should also identify variables that affect the rate of false-positive tests. For example, if AFP levels are consistent over the course of an entire study, it is unlikely that the results will vary significantly over time.
Assay drift
This may be due to observed assay drift or a change in reagent lots. Significant shifts, on the other hand, may indicate alternative methods of monitoring.
Repeat assay controls
The use of repeat assay controls for ONTD testing is useful in monitoring intra and inter-assay performance variability.
AFP standards should be sufficiently precise to avoid contamination, tampering, or substitution. Assays should achieve the same precision for critical samples using multiple replicates. The reproducibility of AFP results should not be less than 5%. Repeat assay controls should include reproducibility, and the laboratory should be able to confirm the results through appropriate consultation. Repeat assays are a vital part of the quality assurance process.
Patient education
A comprehensive ONTD patient education program coordinates the preanalytical, analytical, and postanalytical components of this process. This includes addressing patient rights and information about treatment options. It also includes addressing costs, risks, and benefits of screening. To make sure patients understand their test results, labs should develop educational materials for patients. Several professional organizations and laboratories have developed excellent materials in multiple languages. Patient education materials should provide information about the disorder, the screening process, and the tests.
External proficiency testing
One of the primary benefits of external proficiency testing is the ability to compare results between participating laboratories. Participating in external proficiency testing can help ensure that the results you receive are accurate and reproducible. Each shipment contains five specimens or sera for each analysis, as well as 15 proficiency test challenges.
The aims of an external proficiency testing program are twofold: to monitor laboratory performance, and to assess the suitability of reagent sources. While these programs are often local, they can be national in scope. In addition, external proficiency testing helps laboratories prove their quality by participating in such programs. This can be especially useful for new or inexperienced laboratories, as well as for laboratories in underdeveloped countries. Furthermore, participation in external proficiency testing programs helps those laboratories that aren’t participating in other testing programs.