Analysis system for a biological sample
The invention provides for an analysis system ( 100, 300, 400 ) for analyzing a biological sample ( 108 ) comprising an analyzer ( 102 ) with an analytical unit ( 106 ) for analyzing the biological sample to obtain an analysis result ( 140 ). The analyzer is configured for receiving a cartridge ( 110 ) comprising an identifier ( 114 ) and containing at least one reagent for analyzing the biological sample. The analyzer comprises an identification unit ( 116 ) for reading the identifier. The analyzer accepts the cartridge if the identifier is valid. The analysis system further comprises a protocol creation system ( 150, 104 ). Instructions cause the protocol creation system to: receive ( 200 ) analysis protocol parameters ( 164 ) from a user interface ( 158 ); generate ( 202 ) a custom analysis protocol ( 138 ) using the analysis protocol parameters; link ( 204 ) the custom analysis protocol to an invalid identifier which changes the invalid identifier into a valid identifier, and transfer ( 206 ) the user created analysis protocol associated with the now valid identifier to the analyzer controller.
1. A method of analyzing a biological sample in an automated analysis system comprising an analyzer, wherein said analyzer is configured for accepting a cartridge with a valid identifier and rejecting a cartridge with an invalid identifier, comprising the steps of:
(a) providing a cartridge comprising an invalid identifier and containing at least one reagent for analyzing the biological sample;
(b) receiving analysis protocol parameters from a user interface, wherein said analysis protocol parameters are selected from the group consisting of an analysis protocol identifier, a cartridge identifier, a channel target assignment, an internal control validity range, a sample type, a sample process input volume, a polymerase chain reaction profile, a calculation sensitivity, dilution factors, incubation time, reagent addition, volumes, temperature settings, washing steps and combinations thereof;
(c) generating a custom analysis protocol using the analysis protocol parameters received in step (b) with a protocol creation system, wherein steps (a) through (c) are interchangeable or may be performed in parallel;
(c) linking the custom analysis protocol to a protocol identifier corresponding to the invalid identifier;
(d) appending the custom analysis protocol to a set of analysis protocols in an analyzer controller of the analyzer, and thereby changing an invalid identifier on the cartridge into a valid identifier such that the analyzer controller accepts the cartridge;
(e) selecting said custom analysis protocol linked to the protocol identifier corresponding to the valid identifier,
(f) loading said cartridge into said automated analyzer;
(g) reading said identifier, wherein the identifier is read by an identification unit comprising an identifier reader comprised in the analyzer; and
(h) analyzing said biological sample using at least one aliquot of said at least one reagent comprised in said cartridge according to the selected custom analysis protocol.
2. The method of claim 1 , wherein the identifier is comprised on an identification tag.
3. The method of claim 1 , wherein the identifier is a unique identifier on the identification tag, and the controller memory comprises a cross-table comprising protocol identifiers corresponding to unique identifiers which assigns a unique identifier to an analysis protocol.
4. The method of claim 2 , wherein the identifier is generated on an identification tag by an identifier generator and the custom analysis protocol is stored with a reference to the protocol identifier.
5. The method of claim 1 , wherein said custom analysis protocol is created on a protocol creation system, and wherein the custom created analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection, wherein the custom analysis protocol is referenced by the protocol identifier.
6. The method of claim 2 , wherein said custom analysis protocol is created on a protocol creation system, and wherein the custom created analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection, wherein the custom analysis protocol is referenced by the protocol identifier.
7. The method of claim 3 , wherein said custom analysis protocol is created on a protocol creation system, and wherein the custom created analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection, wherein the custom analysis protocol is referenced by the protocol identifier.
8. The method of claim 4 , wherein said custom analysis protocol is created on a protocol creation system, and wherein the custom created analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection, wherein the custom analysis protocol is referenced by the protocol identifier.
9. The method of claim 1 , wherein said custom analysis protocol is created on a protocol creation system, and wherein the custom created analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection, wherein the custom analysis protocol is referenced by the protocol identifier.