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FAQs

FAQ

FREQUENTLY ASKED QUESTIONS

1. Instrument

(1) What are the lumilite8 & lumiflx16 for?

This instrument is an immunoassay analyzer for the measurement of multiple parameters from whole blood, serum or plasma with core lab-quality results.

(2) What is the assay principle and methodology of lumilite8 & lumiflx16?

It is a chemiluminescence reaction with detection of light emissions by a photomultiplier tube.

(3) How many tests can be assayed per hour?

Lumilite8: Up to 8 tests per run in less than 15 minutes, about 32 tests per hour.

Lumiflx16: Up to 16 tests per run in less than 15 minutes, about 64 tests per hour.

(4) How heavy is the instrument?

Lumilite8: 12kg.

Lumiflx16: 50kg.

(5) Is the instrument CE marking registered?

Yes. The instrument and 60 reagents are CE marked.

(6) Can it be interfaced to Laboratory Information System?

Yes.

(7) How patient ID can be input?

Either directly through touch panel or by optional barcode reader.

(8) Does the instrument generate any waste?

Waste generated is one reagent cartridge.

(9) Does the instrument require periodical maintenance?

The mechanism of this instrument is simple and hardly broken down. Therefore, daily to monthly maintenance is not required.

(10) Are there parts on the analyzer that need to be replaced regularly?

No.

(11) What is total assay time?

It depends on assay parameter. Cardiac markers require 15 min.

(12) Is 24hours operation possible?

Yes. This instrument is designed for emergency testing, stay on 24 hours a day, 7 days a week.

(13) Do the reagent cartridges need to be set at an appropriate position that is unique to the assay parameter?

No, they do not. The instrument automatically scans the barcode on the reagent cartridges.

(14) Can I ask the way to calibration? How often calibration need to be performed?

This instrument automatically reads master curve information from barcode on the reagent cartridge. Two point calibration by users usually need to be performed once a month and whenever reagent lot is changed.

(15) Does the instrument have STAT function?

No. The instrument is designed for low volume users at an inexpensive price setting. We will recommend higher volume users to purchase multiple instrument.

(16) What about sensitivity and measurement range?

The data shows the sensitivity of hs-cTnl is ≤0.006 ng/ml

2. Reagent

(1) What is the shelf-life of the reagents?

12 months after production.

(2) Can the instrument be operated in “Random Access”?

No. Lumilite8 is a batch analyzer with up to eight tests per run.

(3) How many tests can be carried out per hour?

The lumilite8 can run up to 32 tests per hour.

The lumiflx16 can run up to 64 tests per hour.

(4) What is the reagent cartridges composed of?

It consists of magnetic particles, ALP conjugate, B/F washing solution, chemiluminescent substrate and sample diluents.

(5) Is the selection of particular type of magnetic particles essential for this instrument?

Yes. The selection of the magnetic particle greatly influences on the assay performance.

(6) Are additional reagents needed?

No, all the reagents are contained in the reagent cartridge.

(7) Is a water connection or water drainage needed?

No. The analyzer does not require internal or external tubing.

(8) Which substrate is used?

AP/HRP/AE

(9) Is the enzyme that can be used ALP only?

No. It is a matter of kinetics of chemiluminescent substrate. HRP and any other enzyme can potentially be used once appropriate enzyme are chosen.

(10) What tests are available?

Over 100 parameters & 60 CE marked.

(11) What kind of sample material can be used?

Whole blood, serum and plasma.

3. Marketing

(1) Are you manufacturer or trading company?

Manufacturer. We can provide one-stop services from instrument customization, reagent matching, CDMO to product registration.

(2) Do you have a minimum order quantity?

Yes, we require all international orders to have an ongoing minimum order quantity. Instrument MOQ: 10, reagent: according to specific demand.

(3) Can you supply the relevant documentation?

Yes, we can provide most documentation including Certificates of Analysis / Conformance; Insurance; Origin, and other export documents where required.

(4) What is the average lead time?

For samples, the lead time is about 7 days. For mass production, the lead time is 20-30 days after receiving the payment. If our lead times do not work with your deadline, please go over your requirements with your sale. In all cases we will try to accommodate your needs. In most cases we are able to do so.

(5) Do you accept OEM cooperation?

Yes, it is acceptable. We will study the customer’s business plan.

(6) What kinds of payment methods do you accept?

T/T, L/C, etc.

(7) What is the product warranty?

We warranty our materials and workmanship. Our commitment is to your satisfaction with our products. In warranty or not, it is the culture of our company to address and resolve all customer issues to everyone’s satisfaction.

(8) Do you guarantee safe and secure delivery of products?

Yes, we always use high quality export packaging. We also use specialized hazard packing for dangerous goods and validated cold storage shippers for temperature sensitive items.

(9) How about the shipping fees?

The shipping cost depends on the way you choose to get the goods. By seafreight is the best solution for big amounts. Exactly freight rates we can only give you if we know the details of amount, weight and way. Please contact us for further information.

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