HOW DO I BECOME A DIRECT-CUSTOMER ?
HOW DO I VIEW TECHNICAL CONTENT ON THE LIN-ZHI INTERNATIONAL INC. (LZI) WEBSITE?
HOW MANY TESTS CAN I RUN FROM LZI EIA KITS?
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?
HOW MANY BOTTLES SHOULD I ORDER FOR CALIBRATOR AND CONTROLS?
WHAT ANALYZERS WILL LZI REAGENTS RUN ON?
WHERE CAN I GET CROSS-REACTIVITY INFORMATION FOR A SPECIFIC ASSAY?
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.
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 Testing is 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 guidelines. 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 Testing gives 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 Testing provides 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 testing we 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.
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 email@example.com.
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
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.
COULD I REQUEST FOR AN ASSAY THAT IS NOT CURRENTLY LISTED IN THE CATALOG?
Please contact customer service at firstname.lastname@example.org 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 email@example.com 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?
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 firstname.lastname@example.org for 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 email@example.com or 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 firstname.lastname@example.org or call (408) 970-8811 (ext. 4147) for further assistance.