# US 2013/0157273 A1 · Method for Nucleic Acid Testing

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- Number: US 2013/0157273 A1
- Document ID: US20130157273A1
- Status: Published application
- Kind: A1
- Application number: 13/714,243
- Filed: 2012-12-13
- Published: 2013-06-20
- Earliest claimed: 2011-12-20
- Assignees: Roche Molecular Systems, Inc.
- Inventors: Paul Frank; Andreas Gisler; Alfred Moertlseder; Sascha Roehrig
- Web page: https://patentgrep.com/patent/US20130157273A1

## CPC

- C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence)
- G01N 35/0092: {Scheduling}
- G16B 25/00: ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
- G16B 99/00: Subject matter not provided for in other groups of this subclass
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A Method for nucleic acid analysis involving the steps of receiving sample tubes which contain samples, receiving a test request for each sample (the test request specifying one or more assays to be conducted for said sample), obtaining one or more sample aliquots of each sample depending on if one or more assays are to be conducted, assigning each of the sample aliquots to one or more test classes according to the assay which is to be conducted for that sample aliquot and combining sample aliquots belonging to the same test class into the same batch, while the batch includes samples for which a first and samples for which a second assay is to be conducted.

## Claims

### Claim 1

A method for nucleic add analysis involving the steps of
receiving sample tubes each containing a sample,
receiving a test request for each sample, said test request specifying one or more assays to be conducted for said sample,
obtaining one or more sample aliquots of each sample depending on if one or more assays are to be conducted,
assigning each of the sample aliquots to one or more test classes according to the assay which is to be conducted for that sample aliquot
combining sample aliquots belonging to the same test class into the same batch, said batch comprising samples for which a first and samples for which a second assay is to be conducted,
simultaneous amplification of nucleic acids contained in said batch
conducting an analysis of the sample aliquots to determine the presence and/or concentration of nucleic acids in said sample aliquots.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said assignment step involves the check of a lookup table which shows a corresponding test class for an assay to be conducted.

### Claim 3 (depends on 1)

The method according to claim 1, wherein a first and a second sample aliquot are assigned to the same test class if
a) the sample processing steps are identical, or
b) the same thermal profile for nucleic acid isolation is employed, or
c) the same consumables are employed for the first and second sample aliquot.

### Claim 4 (depends on 1)

The method according to claim 1, wherein a first and a second sample aliquot are belonging to the same batch while reagents employed for testing the first and the second sample aliquot are different.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said obtaining of sample aliquots is done by aspirating a volume of sample and discharging said volume or a portion thereof into a well.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said combining of sample aliquots into a batch is done by pipetting said sample aliquots into different wells of the same microwell plate.

### Claim 7 (depends on 6)

The method according to claim 6, wherein said processing together of sample aliquots is performed by subjecting said microwell plate to a thermal profile such that all sample aliquots in said microwell plate are subjected to the same thermal profile.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the analysis involves the detection of fluorescence light from the sample aliquots.

### Claim 9

A system for analyzing nucleic acid containing samples, comprising:
a sample reception unit in which sample tubes each containing a sample are received,
a reader which reads identifications on the sample tubes,
a data management unit which receives test requests for samples, said test requests are specifying assays to be conducted for the samples, the data management unit further receives sample tube identifications from the reader,
the data management unit determines how many aliquots of a sample are necessary; assigns the sample aliquots to test classes and provides such assignment to a control unit,
the control unit controls a pipettor to pipette sample aliquots having the same test class assigned thereto into the same batch of wells,
the same or a further pipettor for pipetting reagents into the batch of wells,
a thermal unit for subjecting the batch of wells to a thermal profile for amplifying nucleic acids,
a detection unit which detects signals from the batch of wells,
an evaluation unit which determines the presence and/or quantity of nucleic acids in the wells of the batch.

### Claim 10 (depends on 9)

The system according to claim 9 further comprising a purification unit which purities nucleic acids contained in the wells.

### Claim 11 (depends on 9)

The system according to claim 9, wherein the data management unit has stored therein a lookup table which assigns each type of assay to at least one test class.

### Claim 12 (depends on 9)

The system according to claim 9, wherein the thermal unit has two or more segments which perform different thermal profiles.

### Claim 13 (depends on 9)

The system according to claim 9, wherein the batch of wells is provided by a unitary microwell plate.

### Claim 14 (depends on 9)

The system according to claim 9, wherein the detection system is a fluorescence detection system comprising an illumination unit for illuminating sample aliquots located in sample wells and further comprising a detector for detecting fluorescent light emitted from the sample wells.

### Claim 15 (depends on 9)

The system according to claim 9, wherein the data management unit receives the sample orders from a laboratory information system (LIS).