CGx Panel
FDA-Cleared Monkeypox Molecular Testing Laboratory
The Diagnostic Results Needed for Fast and Effective Healthcare Solutions
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Diagnostic testing for the orthopoxvirus, including the Monkeypox viral infection, empowers clinicians with results. LUX Diagnostics offers DNA assay testing developed by the CDC and cleared by the FDA to effectively identify the disease by searching for the virus DNA.
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We provide trusted data from our state-of-the-art laboratory to allow medical providers to make informed decisions and treatment plans. Our testing capacity, innovative equipment, software integration, and speed gives healthcare providers and patients reliable results.
CGx Result Categories
The results from the sample will report as detected, not detected, equivocal or inconclusive.
Detected
The test indicated the presence of a non-variola orthopoxvirus.
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Not Detected
The test did not detect the orthopoxvirus, which indicates a negative result for Monkeypox.
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Equivocal
The sample does not produce a definitive result because the level of the virus is too close to the detection limit. The CDC recommends collecting a new sample to test.
The CGx Testing Process
Simple and proven testing to improve healthcare outcomes through effective diagnostics.
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The healthcare provider collects a sample by swabbing or brushing one of the patient’s lesions using a sterile swab.
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Insert the swab into the approved tube and securely close the sample. Accurately label the sample for transport to the laboratory.
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The healthcare provider sends the secure sample to LUX Diagnostics.
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LUX Diagnostics processes the sample using innovative PCR testing technology.
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The healthcare provider can access the patient’s results via the LUX LIMS portal.
We uphold the highest standards for secure and valid testing to produce accurate results.
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What Is PCR Testing for the Monkeypox Virus?As new viruses emerge, PCR testing provides fast and accurate diagnostics. PCR stands for a polymerase chain reaction and is the gold-standard method for detecting the Monkeypox virus from lesion swabs. This type of molecular testing examines the DNA to determine if the virus is present in the patient. PCR tests can help prevent the spread of disease through early and precise diagnostics.
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How are Results Reported for the PCR Monkeypox Test?The laboratory tests the sample for the presence of DNA from non-variola orthopoxvirus species. Monkeypox is one type of orthopoxvirus. Currently, no other viruses in the species raise an issue for public health; therefore, the CDC deems any positive result as Monkeypox.
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When to Order Monkeypox Testing?The CDC only recommends testing for patients with a rash or lesions consistent with the Monkeypox virus. The most conclusive results come from samples taken from lesions. The virus only lives in the blood for a short period; therefore, blood tests do not offer conclusive results. The other symptoms of the virus, such as chills, fever, headache, and swollen lymph nodes, mimic symptoms of other common illnesses. Consider conducting additional diagnostic testing to rule out other viruses, like COVID-19.
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How Long Does It Take to Receive the Monkeypox Test Results?The PCR test results take approximately three days to process and report. While waiting for the results, follow the CDC guidelines to prevent the spread of infection.
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What is the clinical laboratory test principle for CCM, polypharmacy, and toxicology testing?In our laboratory, we employ immunoassay, LC-MS, and ICP-MS testing methods to attain exceptional sensitivity and specificity. This approach minimizes the likelihood of errors such as false positives and false negatives.
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What Is the Retention Period of Drugs in an Individual's System Following Consumption?The period during which drug usage can be identified is contingent upon the nature of the drug in question and a range of influencing factors. It is feasible to detect the presence of numerous substances solely in cases of recent consumption or prolonged use, influenced by several parameters including: - The pharmacokinetics of the drug, specifically its half-life or the rate at which it is metabolized and eliminated by the individual’s body, - The individual's state of hydration, - The frequency with which the drug is consumed, - The mode of administration of the drug, - The established cut-off concentration for the detection test. In general, the presence of drugs in an individual's system can range from hours to weeks contingent upon the specific substance involved.
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Does Toxicology and CCM Panels Produce False Positives?Our confirmatory toxicology and CCM testing is based on the UHPLC-MS/MS, which stands for Ultrahigh Pressure Liquid Chromatography-Tandem Mass Spectrometry and yields the least false positive results in toxicology testing due to its high specificity and sensitivity. This method separates compounds using liquid chromatography and then identifies and quantifies them with high precision through mass spectrometry, not once but twice (tandem). The double mass spectrometry process allows for a detailed analysis of the molecular structure of the compounds, making it extremely effective at distinguishing between substances that are structurally similar. This capability significantly reduces the chance of cross-reactivity and, thus, false positives, making LC-MS/MS one of the most reliable and accurate tools in toxicological analysis.
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What does Cut-Off Concentration Level refer to?The cut-off concentration level in quantitative analytical methods refers to the predefined threshold that determines whether a test result is considered positive or negative for a specific substance. It is the minimum amount of the substance that must be present in the sample for it to be detected by the test. This threshold is crucial for ensuring the reliability and accuracy of the test by reducing the chances of false positives or false negatives. In the context of drug testing, for example, the cut-off concentration is the smallest concentration of the drug or its metabolites that must be present in the sample for the result to be reported as positive, helping to distinguish between incidental exposure and actual use.