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ROCHE ANALYZER INTERFACING GUIDE

Roche Cobas AmpliPrep Bi-Directional LIS Interfacing Guide

Complete engineering specification, HL7/ASTM protocols, pinouts, and parameter mapping for Roche Cobas AmpliPrep on AILS Cloud LIMS.

Roche Cobas AmpliPrep Analyzer - AILS LIS Interfacing Guide
Manufacturer
Roche
Protocol
ASTM E1394 / TCP-IP
Interface Mode
Uni-Directional
Throughput
Batch Processing

1. Roche Cobas AmpliPrep Interfacing Overview & Diagnostic Workflow

The Roche Cobas AmpliPrep is an advanced diagnostic system utilizing real-time fluorescence thermocycling technology for hormones, tumor markers, cardiac biomarkers, infectious serology, and molecular pathogen detection. Integrating the Roche Cobas AmpliPrep with AILS Cloud LIMS standardizes cut-off index (COI) calculations, calibrator curve tracking, and electronic batch signing.

Run Batch & Well Plate Allocation

AILS exports 96-well or 384-well plate setup layouts to the Roche Cobas AmpliPrep, linking sample accession IDs with internal positive/negative amplification controls.

Cycle Threshold (Ct) Curve Ingestion

Real-time cycle threshold (Ct) values and baseline-subtracted fluorescence metrics are ingested directly, automatically classifying qualitative pathogen detection (Detected / Not Detected / Indeterminate).

2. Roche Cobas AmpliPrep TCP/IP Socket & Network Configuration

Hardware & Socket Configuration

TCP/IP Client Socket Connection (Port 5001). MLLP / ASTM Framing.

Protocol: ASTM E1394 / TCP-IP
Interface Mode: Uni-Directional
Default Speed: N/A (TCP Network)
// TCP/IP MLLP SOCKET WRAPPER NETWORK
[Instrument IP Client]            [AILS Gateway Server]
Socket Address   ------------->  Static IP : Port 5001
Start of Block   ------------->  <VT> ASCII 0x0B
End of Block     ------------->  <FS><CR> ASCII 0x1C 0x0D
Payload Standard ------------->  ASTM E1394 / TCP-IP
KeepAlive Probe  ------------->  Bi-Directional ACK (AA)
Verified with AILS Gateway Daemon & Real-Time Socket Router.

3. Roche Cobas AmpliPrep ASTM E1394 Record Frame

Below is a validated communication frame transmitted between the Roche Cobas AmpliPrep and AILS LIS middleware:

<STX>1H|\^&|||Cobas AmpliPrep|||||||P|1394-97|20260815140000<CR><ETX>4D<CR><LF>
<STX>2P|1||||Harris^Mark|||M<CR><ETX>2E<CR><LF>
<STX>3O|1|ACC2026081516||^^^HIV1_PREP|||||||A<CR><ETX>4F<CR><LF>
<STX>4R|1|^^^EXTRACT_STATUS|COMPLETE|||N||F<CR><ETX>3A<CR><LF>
<STX>5L|1|N<CR><ETX>0A<CR><LF>

4. Roche Cobas AmpliPrep Clinical Parameter LOINC & Reference Range Dictionary

Instrument Code LOINC Code Clinical Parameter Name Standard Units Default Reference Range
EXTRACT_STATUS 6770-3 Extraction Batch Status Status Completed
RACK_ID 6771-1 Output Tube Rack Barcode ID Valid

5. Roche Biomedical Engineering Field Notes & Gotchas

1

AmpliPrep connects as TCP Client to AILS Gateway Server on Port 5001.

2

Verify that sample rack accession barcodes match extraction batch manifests.

3

Ensure AILS audit log records operator ID and reagent cassette expiration dates.

TECHNICAL FAQ

Frequently Asked Questions: Roche Cobas AmpliPrep LIS Interfacing

Common biomedical engineering questions regarding connection, worklist setup, and data capture with AILS Cloud LIMS.

Q: What interface protocol does Roche Cobas AmpliPrep use?

Roche Cobas AmpliPrep uses ASTM E1394 protocol over TCP/IP socket connection.

Q: How does AmpliPrep link with downstream PCR instruments (e.g. Cobas TaqMan)?

AILS LIMS links the AmpliPrep extraction tube rack barcode directly to the downstream PCR run plate map.

Q: What parameters are tracked during AmpliPrep extraction?

Sample ID, extraction protocol name, reagent kit lot number, extraction timestamp, and completion status.

Q: Does AmpliPrep support bi-directional worklist verification?

Yes. AmpliPrep queries AILS Gateway to confirm sample tube eligibility before dispensing extraction reagents.

Q: How does AILS handle internal control dispensing validation?

Internal control dispensing confirmation transmitted in the ASTM stream is verified before releasing results for PCR amplification.

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