iLsa Diagnostic Manufacturing and Diagnostics | iDC 20
Pathology

iLsa Diagnostic Manufacturing and Diagnostics | iDC 20

iLsa has the benefit of over 40 years of experience in the relevant and field; it comprises of two divisions, iLsa Manufacturing and iLsa Diagnostics.

Description

Automated Liquid Based Cytology System with a throughput of up to 40 slides per hour for providing consistently reproducible mono-cell smear quality with unparalled ease of reading with highest level of economy.

Measurement Principle

Based on the innovative and classic method of “DOUBLE CENTRIFUGATION” with integrated turbidity measurement to ensure constant and reproducible singe cell smear.

Major merits
  1. Several manual and automated methods are employed for smear preparation including centrifugation, sedimentation, filtration, blotting and depositing.
  2. "Liquid based method" allows a thin single layer to be obtained.
  3. If abnormal cells are identified, same suspension can be sent to lab for HPV for further processing by molecular biology techniques.
  4. Avoids the need for reprocess, and offers better patient care and turn around time.
  5. The unique controlled centrifugation process, integrating infra-red detection system incorporated to determine cell concentration and provides consistent results.
  6. Ensures REPRODUCIBLE, HOMOGENEOUS, SINGLE CELL quality for optimum cell detection and unparalleled repeatability.
  7. Guarantees TOTAL SECURITY AND ZERO RISK contamination, critical needs of the lab.
  8. Full traceability from sample to slide assured, without the danger of operator error with complete audit trail.
  9. Time tested centrifugation technique, the reference method adopted.
  10. Largely eliminates cell debris and parasitic material for better presentation and visualisation needed for diagnosis.
  11. Offers "systems approach" for automation with reliable results, and virtually eliminating error prone steps.
  12. Complete supply of hardware and consumables with vertical compact shaker accessory for homogenous sample, most compact automated slide stainer, and all relevant consumable covering sample collection and processing steps and as one stop shop.
  13. Cells preserved in native condition and non toxic preservative liquid used for processing.
  14. Permits usage of sample for immuno histochemical tests without limitation.
  15. IDC 20 helps in the preparation of monolayer slides for smear, which can be conveniently read for visual analysis (microscope) or with image acquisition and digital processing via scanner.
  16. REAL monolayer slide, offering real monoplane for faster reading
  17. The liquid in the vial can be used to perform HPV test on the other instruments for further processing as those from Abbott®, Roche®, Qiagen® and so on, offering higher level of flexibility.
  18. Offers a higher level of flexibility in testing
  19. The system is well suited for labs handling between 25 to 400 samples per day.
  20. Well suited for small to high workloads and at the time same level of economy of operation
  21. The realistic cost per sample preparation including the collection set and the dedicated consumables is one of the lowest in the industry and saving a significant amount over a period in the high workload centers.
  22. The realistic running cost with IDC20 does not depend on no of samples, and while comparing with systems for similar applications offers BEST life cycle cost.
Technical specifications
Principle
Double centrifugation with integral reading for reproducibility
Capacity
Batch of 20 specimen bottles maximum.
Throughput
40 Samples per hour
Specimen volume max
20 ml
Dispensing
Volume based on cell density measurement, with disposable tip for reduced carry over.
Sample id
Barcode
Display
Touch screen tablet, with on board software.
Data tracked
Date, time, user id, bar code, turbidity.
Compliance
IVD CE
Power
230V 50Hz
Clinical Applications

LBC is a new method for preparing cervical samples for cytological examination. In contrast to the conventional smear preparation, this involves preparation of suspension of cells from sample and used to produce a thin layer of cells on a slide, finds applications in both gynaecological and non gynaecological areas, thyroid, cyst, oral pathology(lesions) for body fluid like urine, pleural effusions, brushing sample (eg. gastrointestinal) tract, lump and FNA (lesions)

  1. Overcomes limitations of conventional cytology
  2. Future benefits include extra tests- HPV, Chlamydia, Neisseria and Gonorrhea.
Buyer’s specifications

Automated liquid based cytology system for a throughput of about 40 slides per hour for providing consistently reproducible mono cell smear equally with ease of reading and economy of cost in a compact table top design.

Features:

  1. System shall be controlled by a touch screen with simple interface calling for less than two hours of typical operator training.
  2. Preferably based on referral centrifugation principle with facility to ensure constant reproducible single cell smear.
  3. Shall be with the process of sample collection from bottle to brush to ensure 100% of the collected cells for the processing.
  4. Should have minimal carry over and contamination with disposable tips during the processing for constant quality.
  5. High quality slide preparation with no cell clusters, clean cell separation, no deformation with large rectangular spot that shall be homogenous and reproducible as a result of fully automated slide preparation.
  6. Shall be suitable for all applications gynaecological and non-gynaecological and smear process, preferably with repeatability of the order of less than 2%.
  7. Calculation of cellular concentration by integrated infrared sensor to measure turbidity and thus determine all cell concentration of the sample and then deposit required volume on slide to ensure consistently correct quantity of cells is present on slide.
  8. The system process shall be capable of separation to eliminate cell debris and parasitic material like blood, mucus, providing better visualisation of the cells as needed for better diagnosis and reduce the number of unsatisfactory test.
  9. System shall ensure real mono layer slide, homogenous and reproducible providing for faster analysis, digitally or with microscope, ensuring real monoplane spreading and avoiding the need for focal adjustment.
  10. The system shall ideally involve non toxic preservative liquid for operator safety and safe disposal. Shall employ ethanol with no methanol at all, with a storage period of around two years without sample collection, and 90 days with sample collection.
  11. Should permit the usage of liquid in vial also to perform test for HPV by RT-PCR from standard manufacturers.
  12. The principle of centrifugation shall be free from the disadvantage of stopping big cells or cellular material resulting in lack of environmental elements or real matrix(mycosis) on the slide.
  13. The system configuration shall be free from cell deformation and lacking classification depending on the cell size. It should be possible to handle immuno cyto chemical test with the preserved cells.
  14. The LBC device shall involve not more than five minutes of hands on time to process a batch of 20 samples loaded for analysis, providing a throughput of 40 slides in an hour approximately.
  15. Total security with full traceability from bottle to slide and bar-coded recognition before sample distributed with flagging of any operator error.
  16. Full traceability with all data storage and accessible in simple excel file.
  17. Vertical shaker accessory to separate heap of cell to dissolve mucus, and adaptable to different bottle sizes and effective to obtain a homogenous fluid smear to handle at least 40 specimen bottles per run.
  18. System shall be supplied complete with one additional set of accessories for processing when system is in operation. Appropriate automated freely programmable stainer for handling at least 10 slides simultaneously can be quoted under option separately as per broad specifications attached.

System should permit being fitted with optional GSM device to provide remote and real time consumption read out, to facilitate easy stock management of consumables and also aid in automatic stock replenishment.

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Frequently Asked Questions
General
What is the principle of operation of the system ?

The system is  based on the unique principle of controlled double centrifugation with calculation of cellular concentration wise advantages of 

  • no cell clusters 
  • well separated cells without deformation 
  • more elements to facilitate better diagnosis,- pathological germs, mycelium, etc)
  • rich background on the slide with all advantages of conventional smear without the disadvantage.
What are the unique merits of the system compared to similar machines available?
  • Unique double centrifugation, 
  • calculation of cellular concentrate for homogenous and reproducible process 
  • non toxic (no methanol) preservative ensures better operator safety 
  • cell preservation allows possibility to carry out immune-cytochemical tests 
  • of the collected cells 100% to test, thanks to brush in bottle approach 
  • same container for gynaec and non-gynaec applications.
  • enrichment of cells  enhanced with vertical agitation additionally 
  • even in case of low cell concentrations, there remains medium for HPV test 
  • high productivity with 40 slides per hour.
  • very economical to run with fewer consumables, less manual steps, open choice of staining solutions and protocols
  • real monolayer slides, cell structure conserved, single focal depth with richer background 
  • fully automated process for non-gynaec applications
What are the various consumables involved?

It involves consumables related to cervical sample collection, common  with all system and lower cost consumable dedicated for  use with the LBC system, and  overall lower cost per sample.

Does the cost per sample depend on no of samples run as batch?

No, same running cost for one or  twenty samples run at the same time.

Is it mandatory to include the vertical shaker and the mini slide stainer options ?

The vertical shaker is a mandatory accessory and hence included in the standard quote,  and necessary to separate heap of cells to dissolve mucus by vertical agitation.

The micro stainer is a very cute companion system, meant for handling small no of samples for special staining which includes H&E and intraoperative staining which can be used for pathology, cytology and microbiology and is an open system. Not a must but of  practical utility offering affordable automatic staining.  Need not be considered if stainer is available and or manual staining of consistently good quality can be ensured, if involving smaller work load.

What singular benefit is achieved by double centrifugation as against the widely used filtration by most other systems?
  • The centrifugation process has been validated for over 40 years and considered THE REFERENCE method for liquid cytology
  • The filtration process suffers from the biggest disadvantage of  “STOPS BIG CELL” or cellular material that is lacking matrix elements (mycosis) on the slide !
What are the major advantages of two times centrifugation over the systems with filter with vacuum and transferred to microscopic slides?

No cell deformation, no classification depending on cell size.

Is slide scanner offered for further image analysis with cell sorting software for HPV screening?

No, slide stainer is not offered by ILsa and there are several companies offering  the product with cytology artificial intelligence. Please call for details if required.

What is the type of collection fluid employed in the LBC system?

The special collection fluid is safe and contains no hazardous material like methanol as is the case with  some systems.

Does the collecting fluid have any other function beyond (i)collection(ii)fixing (iii)homogenizing (iv)rinsing of cells?

No other functions are involved.

How does the combination of LBC and cell paint stainer effectively improve the deficiency normally encountered in terms of PAP smear including
  • less sensitivity
  • false negative results which can be as high as 50% with PAP
  • around 67% of false negative results attributed to improper sampling
  • cells observed by mucosa or blood or inadequately preserved
  • thicker and thinner, that is unevenly spread areas
  • air drying artifact
  • artifact including “nuclear feathering”.

ILsa LBC system is based on centrifugation, which allows to get real monolayer slide and decreases number of “errors” compared to PAP smear  – A VERY BIG MERIT.

Does the approach especially with the double step centrifugation reduce or eliminate typical problems with LBC like (i) cell nucleic take on more vesicular, delicate appearance (ii) cause some epithelial cells to round up and appear smaller (iii) nuclear to cytoplasmic ratio altered in favour of nucleus ?

The best proof is to access the photos of the slides obtained with ILsa20 to get an idea about the clarity and ease of diagnosis.

Is it correct that iDC20 LBC system is capable of handling without limitation non-gynaecologic cyto preparation applications including (i) thyroid cyst fluid examination (ii) diagnosis of various oral lesions (iii) body fluids like urine, pleural effusions, (iv) gastrointestinal tract lung and FNA ?

Yes, but this will not be case of  automatic protocol and depending on test, user has to do  manual pre preparation, and non-gyn tests are very often developed according to specific preferences of the labs

What is the preservative (example ethanol or methanol based) employed in sample vial, since this can determine storage period of vial as claimed by some competitors upto two years without sample, or 30 days with the sample collection and so on ?

In case of IDC20 liquid is ethanol based, with no methanol, a teratogenic alcohol that is very toxic. The storage period is around two years and 90 days with sample collection.

Is it possible to store or use residual sample for other applications over a period of say 4, 8 or 24 weeks ?

Three months (90 days) for HPV, and there is no clear notification for other applications

What would be the recommended ideal annual sample load handling capacity with iDC 20?

It is well suited to handle samples between 10,000 and 50,000 slides per year with iDC20

What would be the recommendation in terms of maximum number of samples per annum with iDC 20 that can be handled considering a typical eight hour working day?

50,000 is the ideal upper limit.

What is the approximate number of samples that can be processed in about an hour’s time with iDC 20 ?

About 40 samples

What would be the typical hands on time for loading a batch of 20 samples for analysis ?

About five minutes

Can the additional set of tube and sample tray provided be pre-programmed and probably barcoded externally, when one set is on the run to improve the turn around time ?

One additional tray is provided as stated at no extra cost.

Is the pipetting tip of special type or any good quality blue tip from standard manufacturer can be employed ?

It is absolutely mandatory to use only ILsa specific tips due the fact that turbidity is measured through them

Is the centrifuge chamber of washable or reusable type or 100% disposable ?

It is one time use disposable as physical properties are lost when washed and reused, and contamination possibility is a major risk and final performance can be severely compromised if reused.

Can the dedicated labels for use with bottles and slides be sourced locally, for logistic reasons ?

No, they cannot be sourced locally unless labels are solvent resistant for staining and suggested to use only printer delivered with iDC20 and barcode should be comparable to the ones from Zebra printer, for recognition by iDC20 laser

Does the system ID20 involve usage of brush of sample collection process ?

Gynacologists collect sample and leave the head of the brush within vial.