WHAT SIZES ARE LZI PRODUCTS?
- A small kit contains 100mL of R1 and 37.5 mL of R2.
- A large kit contains 1000mL of R1 and 375 mL of R2.
- Calibrators and controls come in 5mL bottles.
- Multi-calibrators and controls come in 15 mL bottles.
HOW MANY BOTTLES SHOULD I ORDER FOR CALIBRATOR AND CONTROLS?
This depends on the frequency which the end user tests their samples. Our manufacturer’s recommendation is that customers calibrate the reagent weekly and run controls daily.
The calibrators and controls come in 5mL bottles = 5000uL and usually the lab will do two squeezes of the calibrator or control, which will be about 200uL each time to fill a sample cup.
5000uL ÷ 200uL = 25 uses per bottle and how long everything lasts entirely depends on how frequently each lab calibrates and runs the controls.
Based on manufacturer’s recommendations, if samples are run/tested daily, one bottle of control will last approximately 25 business days and 1 bottle of calibrator will last approximately 6 months. If the lab calibrates daily, then 1 bottle of the calibrator will last approximately 1 month.
Please note that these numbers are estimated without taking into consideration of re-calibration or troubleshooting.
WHAT IS THE SHELF-LIFE OF YOUR PRODUCT?
As long as the products have been kept under manufacturer recommended conditions, all LZI reagents, calibrators, and controls can be used until the expiration date printed on the products. The recommended conditions include keeping the solution in the original bottle, stored at 2-8°C, and closed following each use.
WHY IS THERE LEFT-OVER REAGENT IN MY R1 OR R2 BOTTLE?
Our reagents are bottled to provide at least 500 tests (small kit) on a Hitachi 717 instrument. Since different analyzers use different parameters, this leads to an inconsistent volume of reagents used during testing. As a result, this alters the rate each bottle is used leading to leftover reagent.
CAN LZI SETUP THE ASSAY AND ASSIST WITH THE MODERATE COMPLEXITY VALIDATION ON OUR ANALYZER?
We do not have the manpower to assist in lab validations. However, LZI does provide a discount pricing for customers to validate the interested assay on their clinical analyzer. Prior to purchase, customers must obtain a validation letter to receive the discount for a limited time. To request a validation letter, please contact customer service at firstname.lastname@example.org.
HOW DO I KNOW WHICH MULTI-CALIBRATOR SET TO USE?
To find out what analytes are present in each Multi-calibrator set, refer to the Product Catalog. The assays each set can be used with can be found on the Multi-Analyte Calibrator/Control Concentrations Summary PDF on the LZI website.
HOW DO I BECOME A DIRECT-CUSTOMER ?
Please submit a new customer inquiry and one of our associates will get in touch with you to set up an account with us.
WHY WAS MY ORDER NOT PROCESSED?
- For purchase orders sent before 2:00PM (Pacific Standard Time, PST), a confirmation email will be sent out within 3 hours of order receival and processed to be shipped out the same day. For account status inquiries, please contact our Accounting Department at email@example.com further assistance.
- Incorrect item number written on the purchase orders could delay order process as well. Please check with our current catalog to see if the correct catalog or item number was used. For a copy of the catalog, please email customer service at firstname.lastname@example.org visit our website to see our current urine and oral fluid catalogs.
WHAT IS LZI’S RETURN POLICY?
LZI does not accept returned goods unless these items fail LZI’s internal QC specifications or were shipped incorrectly. All problems concerning received products must be reported within 10 business days to be considered for return or replacement.
- Please contact customer service at email@example.com call (408) 970-8811 (ext. 4147) for further assistance.
WHAT IS LZI’S MANUFACTURER’S GUARANTEE?
All finished goods are shipped with the guarantee of greater than or equal to 6 month shelf-life stability. Special requests such as needing longer expiration dates or requesting specific lots should be requested with the original purchase order via email to firstname.lastname@example.org.
LZI Assay Questions
HOW DO I VIEW TECHNICAL CONTENT ON THE LIN-ZHI INTERNATIONAL INC. (LZI) WEBSITE?
- If you have a LZI website account, please log in to your accountto have access to view the pdfs on the website.
- Website access is granted to direct LZI customers and distributors.
- If you do not have a LZI website account and wish to have one, please send your request to email@example.com with your full name and the name of your company.
WHERE CAN I GET CROSS-REACTIVITY INFORMATION FOR A SPECIFIC ASSAY?
For cross-reactivity information, please email customer service at firstname.lastname@example.org or call us at (408) 970-8811 for further assistance.
COULD I REQUEST FOR AN ASSAY THAT IS NOT CURRENTLY LISTED IN THE CATALOG?
Please contact customer service at email@example.com or call (408) 970-8811 to be placed on the Customer Notification List. When the product is available, a notification will be sent out informing of the product release.
WHERE CAN I GET A COPY OF A PARAMETER SHEET FOR A PARTICULAR INSTRUMENT?
Please send parameter sheet requests to firstname.lastname@example.org or call (408) 970-8811 for further assistance.
WHY DO THE PARAMETER DOCUMENTS HAVE (DRAFT) WRITTEN ON TOP?
While many of our assays are FDA 510(k) cleared, parameter sheet for assays that does not have CLIA Categorization or have never been validated on that analyzer will have “Draft” written on top. The same method is applied for product inserts for non-FDA 510(k) cleared products (that are NOT CE Marked).
WHERE IS THE INDIVIDUAL SDS SHEET FOR MY SPECIFIC ASSAY?
Technical sheets such as product inserts and Safety Data Sheets are available on the website for customers with LZI account. To request login access to the LZI website, please contact customer service at email@example.com or call (408) 970-8811 and provide your name, company name, phone number, and email address to get started.
ARE LZI ASSAYS CLIA CATEGORIZED?
To search for CLIA Categorization of LZI assays, visit the FDA database and input under Test System Manufacturer: Lin-Zhi International. It will then pull up all our assays categorized on which particular instrument.
For example, LZI BUP EIA is moderately categorized on the Beckman AU480 analyzer. At the top of the page it states the name of the assay, instrument, and has classification listed as moderate.
HOW MANY TESTS CAN I RUN FROM LZI EIA KITS?
This depends on which clinical analyzer and what parameters are being used. Generally, a small kit can provide approximately 500 to 900 tests and a large kit can provide approximately 5000 to 9000 tests.
- If you would like to know the number of tests for a specific analyzer, please contact customer service at firstname.lastname@example.org call (408) 970-8811 (Ext 4147) for further assistance.
HOW MANY TESTS CAN AN AU INSTRUMENT GET WITH A SMALL KIT?
Depending on the assay, a small kit can be used to conduct around 800 to 900 tests on the AU.
For a large kit, the AU instruments can conduct 10 times more the number of tests.
HOW MANY TESTS COULD I GET OUT OF THE SAMPLE KIT?
A sample kit can be used to conduct 100 tests, but the number of tests can vary based on the instrument and the parameters used.
WHAT ANALYZERS WILL LZI REAGENTS RUN ON?
LZI reagents can be used to run on any clinical analyzer that can read at 340 nm, such as the Hitachi 717, AU Systems, Easy RA, and etc.
WHAT IS THE DIFFERENCE BETWEEN QUALITATIVE, SEMI-QUANTITATIVE, AND QUANTITATIVE TESTING?
LZI Enzyme Immunoassays are 510(k) cleared for qualitative or semi-quantitative testing ONLY.
- Qualitative Testingis used to test for the presence or absence of a targeted drug of interest. Qualitative results are reported as positive or negative based on a specified cut-off concentration. Many of the cutoffs LZI uses are based on SAMHSA If the absorbance rate of the sample is higher than the cutoff concentration absorbance rate, the result will be positive; if the absorbance rate is lower than the cutoff concentration absorbance rate, the result is negative.
- Semi-Quantitative Testinggives an approximation of how much quantity of a particular drug is in a sample based on known concentrations from a five (or six) point calibration curve. Although clinical analyzers may give a single numerical value when reporting semi-quantitative results, these results indicate the extrapolated numerical value based on the results of the calibration curve. Values are considered semi-quantitative because the immunoassay, which is based on an antibody, may reflect a cross-reactivity of the antibody to other analytes aside from the target analyte.
- For example, an antibody may detect the analyte of interest as well as other structurally related compounds. The resulting absorbance values are then a combination of not just the single analyte of interest but all the compounds that were recognized by the antibody.
- Quantitative Testingprovides a specific concentration of how much of a particular drug is in a sample. The only LZI assay that qualifies as a Quantitative test is the Ethyl Alcohol assay. This assay is an enzymatic assay (enzyme based) rather than an immunoassay (antibody based) and therefore does not have cross-reactivity issues that can be found with immunoassay testing and has therefore been 510(k) cleared as a quantitative assay.
WHAT PRODUCTS DO I NEED FOR QUALITATIVE AND SEMI-QUANTITATIVE TESTING?
- For Qualitative testing we recommend: Reagent, Negative calibrator (0 ng/mL), Cutoff Calibrator, Negative control (aka Level 1 Control), and Positive control (aka Level 2 Control)
- For Semi-Quantitative testingwe recommend: Reagent, Negative calibrator (0 ng/mL), Low Calibrator, Cutoff Calibrator, Intermediate Calibrator, Intermediate Calibrator #2 (NBUP EIA only), High Calibrator, Negative control (aka Level 1 Control), Positive control (aka Level 2 Control)
The specific concentrations and reference numbers can be found on the LZI Product Catalogs.
WHAT TESTS/ASSAYS CAN I USE THE MULTI-ANALYTE CALIBRATORS AND CONTROLS WITH?
- Multi-Analyte Set C: AMP 500, BARB 200, BZO 200, COC 150, MAMP, MTD, OPI 2000
CAN LZI ORAL FLUID REAGENTS BE USED WITH THE QUANTISAL COLLECTION KITS?
LZI Oral Fluid Reagents cannot be used with the Quantisal Collection Kits because we found in studies conducted that the collector kits dilutes the fluid sample and the pad present in the collector kits tends to retain the analyte. We recommend using a collector that can collect a neat sample, this type of collector we also sell here at LZI based on quantity needed.
- For customers that get FDA reimbursement for testing, we would strongly recommend purchasing one of our FDA approved Oral Fluid Assays (OF 6-AM, OF AMP, or OF MAMP) and the LZI collector kits we sell.
CAN LZI ORAL FLUID KITS BE USED WITH THE INTERCEPT COLLECTION DEVICE AND WOULD USING A DIFFERENT COLLECTION DEVICE NEGATE THE FDA CLEARANCE?
Using a different collection device DOES mean that you are using a NON FDA 510(k) cleared product. At this time we do not have the studies done to show that our reagents work with the Intercept collection device, but we do have a few FDA 510(k) clearances of our own reagents with our own LZI collectors (OF 6AM, OF AMP, and OF MAMP).
DOES LZI SELL ADULTERANT TESTS?
LZI does not sell adulterant tests but these products can be purchased from Axiom Diagnostics.
Please visit Axiom at ( http://axiomdiagnostics.com/ ) for further details.
CAN LZI PROVIDE ASSISTANCE WITH CLIA TESTING AND ACCREDITATION?
LZI does not provide assistance with CLIA testing and accreditation. Customers inquiring about CLIA are recommended to search “Clinical Laboratory Improvement Amendments (CLIA)” online for further assistance.