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 customerservice@lin-zhi.comor call (408) 970-8811 (Ext 4147) for further assistance.

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.

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.

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.

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.

• 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.

• Multi-Analyte Set C: AMP 500, BARB 200, BZO 200, COC 150, MAMP, MTD, OPI 2000

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.

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).

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.

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.