ClearPrep cytology is a partially-automated methodology that produces high quality, true monolayer slides. Numerous split sample and parallel clinical trials comparing ClearPrep to conventional preparations and also to the two leading machine-based technologies have shown that the ClearPrep slides are superior to the conventional preps, and at least as good as the more automated systems. There is strong evidence that the ClearPrep methodology has several advantages, particularly in the areas of glandular cell evaluation, optical clarity and cellularity at a much lower cost.
The commitment to total robotics and automation comes at a price. It is well understood that not all patient samples are created equal, and unless adjustments and allowances are made for difficult and challenging samples, the finished slide will be compromised. The ClearPrep technology allows for “sample specific” adjustments to eliminate mechanical artifacts and reduced cellularity. It is a simple technology that is easily incorporated into the laboratory routine. The system, which helps standardize and enhance the preparation of the finished slide, includes the following components:
ClearPrep Collection Vial
The patented (US Patent No. 9,039,636) ClearPrep collection vial is designed to maximize the removal of the cellular material from the collection device. The internal wall is lined with six ridges that provide resistance to the collection device to assist in transfer of the cellular material from the device to the preservative fluid. The ClearPrep collection vial contains 20 mL of ClearPrep Preservative (see below).
Each ClearPrep Collection Vial contains a buffered alcohol solution which has been engineered to provide maximum preservation of all cell types present in the screening sample. Squamous cells and glandular cells from various anatomical sites, each having different fixation requirements are commonly present, as may be various other cell types. An alcohol concentration that is too high will make some of the cells brittle and become fragmented during the process of the slide preparation. If the alcohol concentration is too weak, some of the cells are inadequately fixed, and are distorted on the final slide, which can compromise the screening process.
ClearPrep Collection Vial
ClearPrep Laboratory Pack includes the items necessary to process 500 samples, as follows
ClearPrep Cytology Solution
The ClearPrep Cytology Solution is a reagent that is formulated to balance chemically with the ClearPrep Preservative. The Cytology Solution facilitates the creation of a true monolayer cellular preparation, promotes cell adhesion to the glass surface to eliminate sample loss during the staining process, and also prevents air drying artifacts.
ClearPrep Balancer is a diluted version of the Preservative, and can be added to the samples prior to centrifugation should the batch of tubes need to be balanced. Because ClearPrep Balancer contains similar buffers as the Preservative it will not compromise the sample.
ClearPrep Centrifuge Tube
The tube has clearly-marked gradients at the critical ½ and 1 ml volumes. This is an important indicator when estimating the proper sample-to-reagent ratio. It also serves as another tool to aid in the standardization of the slide preparation process by marking the volume to be separated from the residual sample material.
The tube has clearly-marked gradients at the critical ½ and 1 ml volumes.This is an important indicator when estimating the proper sample-to-reagent ratio. It also serves as another tool to aid in the standardization of the slide preparation process by marking the volume to be separated from the residual sample material.
The ClearPrep Prep Tray and resin tube rack are designed to facilitate consistency of preparation and facilitate laboratory workflows