Flexible molecular syndromic pcr workflows
AssigneeSiemens Healthcare Diagnostics Inc.
InventorGuido Hennig
Life of this patent
Estimating the term…
Abstract
The present disclosure provides workflows, methods, and systems for performing syndromic polymerase chain reaction (PCR) testing with random and on demand access to both patient samples and assays. The embodiments described herein enable flexible and customized testing of multiple, individual targets for different individual patients. The present embodiments also provide for eluate harvesting and storage for parallel and/or reflex testing. The methods and systems in the present disclosure may enable greater flexibility, faster turnaround times and higher efficiency with lower costs for PCR testing.
Claims22
An automated system for performing real-time polymerase chain reaction (PCR) assays with random access, comprising:
- a random access sample sub-system;
- a random access PCR assay sub-system;
- a PCR reaction sub-system;
- and
- a software and control system to program, control and run diagnostic workflows.
A method for performing random access polymerase chain reaction (PCR) testing by an automated system, comprising:
- receiving, by a laboratory information system (LIS) in the automated system, PCR testing instructions from a medical provider;
- preparing one or more patient test samples as instructed by the testing instructions;
- preparing one or more master mix portions from subcomponents as instructed by the testing instructions;
- performing one or more PCR tests using a combined test volume comprising the one or more patient test sample and the one or more master mix portions;
- obtaining results from the one or more PCR tests;
- and
- communicating the results.
The method of 16, wherein the method further comprises the following steps to conduct reflex testing:
- checking whether a reflex test target has previously been tested and has been stored in memory;
- displaying and communicating the previously tested result if the result is available;
- obtaining a sample eluate from previously stored sample eluates;
- preparing one or more master mix portions;
- performing one or more reflex PCR tests as instructed by the reflex testing instructions;
- and
- communicating results from the one or more reflex PCR tests.
A method of a user interacting with a random access PCR test system to perform a PCR test, comprising:
- (a) selecting, by the user, a patient sample using a user interface (UI) associated with the random access PCR test system;
- (b) viewing on the UI, by the user, instructions transmitted by a medical provider to a library information system (LIS);
- (c) selecting via the UI, by the user, testing parameters for one or more PCR tests, wherein the testing parameters are based on the instructions;
- (d) preparing, by the PCR test system, the patient sample and one or more master mix portions determined by the instructions so that the patient sample and the one or more master mix portions are combined for PCR testing;
- (e) running, by the PCR test system, one or more PCR tests;
- (f) displaying, by the PCR test system, the result of the one or more PCR tests on the UI;
- (g) selecting, by the user using the UI, further reflex testing instructions and/or reporting the results to the medical provider;
- (h) displaying, by the PCR system on the UI, any requested results that may have been previously hidden;
- (i) preparing, by the PCR test system, a sample from a stored sample eluate from the same patient sample and one or more master mix portions as indicated by reflex testing instructions from step (g);
- and
- (j) running, by the PCR test system, one or more PCR tests as indicated by reflex testing instructions from step (g).
Dependencies are inferred from the claim text.