Materials, test organism, and equivalent pressures were identical between the two methods, and the results were essentially equivalent. The Modified Dot-Blot Method’s utility in informing the decision whether to evaluate PPE using ASTM F1671/ F1671M-13 is demonstrated in the publication Comparing ASTM F1671 with a Modified Dot-Blot Method to Evaluate Personal Protective Materials.

Note: The ASTM methods use a common apparatus that serves as a comparator for the modified Dot-Blot apparatus described here. If the PPE fails preliminary screening by this method, it may eliminate the need for evaluation by FDA-recognized standards ASTM F1671/ F1671M-13 (Standard Test Method For Resistance Of Materials Used In Protective Clothing To Penetration By Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration As A Test System) or ASTM F1670/F1670M-17a (Standard Test Method For Resistance Of Materials Used In Protective Clothing To Penetration By Synthetic Blood), which are more resource-intensive.Īs will be described in more detail in subsequent sections, the method consists of securing a cut piece of PPE into the modified Dot-Blot apparatus, exposing the PPE to bacteriophage ΦΧ174 or artificial blood for a set time, and applying vacuum for a set time to test the ability of the PPE to resist penetration. bacteriophage ΦΧ174 (universal viral surrogate) or.The intended purpose of the Modified Dot-Blot Method to Evaluate PPE is to serve as a screening method to evaluate the barrier effectiveness of Level 4 PPE (surgical gowns and surgical drapes) against penetration by clinically relevant artificial test soils.įor a visual depiction of the apparatus, refer to Appendix A.įor step-by-step protocols for testing of PPE materials, refer to Appendix B.PPE materials (such as, gowns and drapes) and.a Dot-Blot Apparatus (for example, Whatman Schleicher & Schuell Minifold I) modified as described in Appendix A,.The physical equipment components needed to execute this method comprise: The Modified Dot-Blot Method to Evaluate Personal Protective Equipment (PPE) is a peer-reviewed method to test the barrier performance of PPE materials against viral surrogate or liquid (artificial blood) penetration. Catalog of Regulatory Science Tools to Help Assess New Medical Devices Technical Description

Dot blot apparatur