New tests launched in October


New Tests

In October 2021, Mayo Clinic Laboratories announced eighteen new tests along with numerous reference value changes, obsolete tests, and algorithm changes.

The new tests that launched in October 2021 by Mayo Clinic Laboratories:

WNVUR | West Nile Virus, RNA, PCR, Molecular Detection, Random, Urine

This test is intended for rapid testing for West Nile virus (WNV) RNA (lineage 1 and lineage 2). An adjunctive test to serology for detection of early WNV infection (ie, first few days after symptom onset). The WNV polymerase chain reaction result may remain positive for a longer time in urine than in blood, serum, and cerebrospinal fluid (7 days or more). This assay should not be used for screening asymptomatic individuals and should only be used to test patients with signs and symptoms of WNV disease.

WNVBL | West Nile Virus, RNA, PCR, Molecular Detection, Blood

This test is intended for rapid testing for West Nile virus (WNV) RNA (lineage 1 and lineage 2). An adjunctive test to serology for detection of early WNV infection (ie, first few days after symptom onset). Blood may provide greater sensitivity for polymerase chain reaction detection of WNV RNA than other sources. This assay should not be used for screening asymptomatic individuals and should only be used to test patients with signs and symptoms of WNV disease.

WNVS | West Nile Virus, RNA, PCR, Molecular Detection, Serum

This test is intended for rapid testing for West Nile virus (WNV) RNA (lineage 1 and lineage 2). An adjunctive test to serology for detection of early WNV infection (ie, first few days after symptom onset). The WNV polymerase chain reaction result may remain positive for a longer time in urine than in blood, serum, and cerebrospinal fluid (7 days or more). This assay should not be used for screening asymptomatic individuals and should only be used to test patients with signs and symptoms of WNV disease.

WNCSF | West Nile Virus, RNA, PCR, Molecular Detection, Spinal Fluid

This test is intended for rapid testing for West Nile virus (WNV) RNA (lineage 1 and lineage 2) using cerebrospinal fluid specimens. An adjunctive test to serology for detection of early WNV infection (ie, first few days after symptom onset). This assay should not be used for screening asymptomatic individuals and should only be used to test patients with signs and symptoms of WNV disease.

288PD | Programmed Death-Ligand 1 (PD-L1) (28-8), Semi-Quantitative Immunohistochemistry, Manual

This test is intended for identification of neoplasms expressing programmed cell death 1-ligand 1.

METRN | Metanephrines, Fractionated, Random, Urine

This test is intended for A second-order screening test for the presumptive diagnosis of pheochromocytoma in patients with non-episodic hypertension. Confirming positive plasma metanephrine results in patients with non-episodic hypertension.

SLYME | Lyme Antibody Modified 2-Tier with Reflex, Serum

This test is intended for diagnosis of Lyme disease. This test should not be used as a screening procedure for the general population.

STICK | Tick-Borne Antibodies, Modified 2-Tier, ELISA, Serum

This test is intended for evaluation of the most common tick-borne diseases found in the United States, including Lyme disease, human monocytic and granulocytic ehrlichiosis, and babesiosis using the modified 2-tier testing algorithm approach. Evaluation of patients with a history of, or suspected, tick exposure who are presenting with fever, myalgia, headache, nausea, and other nonspecific symptoms. Sero-epidemiological surveys of the prevalence of the infection in certain populations, and diagnosis of Lyme disease.

TLYME | Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum

This test is intended for supplemental testing for samples with positive or equivocal first-tier test results for antibodies to Lyme disease causing Borrelia species. This test should not be used as a screening procedure for the general population.

IETG | Interference Evaluation Heterophile, Thyroglobulin Tumor Marker, Serum

This test is intended for evaluation of suspected interference form heterophile antibodies causing a falsely elevate thyroglobulin result.

TGII | Thyroglobulin, Interference Interpretation

This test is intended for interpretation for the evaluation of suspected interference from heterophile antibodies causing a falsely elevated thyroglobulin result.

TGQN | Thyroglobulin, Interference Interpretation

This test is intended for quantitative thyroglobulin measurement as a part of evaluating suspected interference from heterophile antibodies causing a falsely elevated thyroglobulin result.

TGABI | Thyroglobulin Antibody, Serum

This test is intended for initial testing as a part of evaluating suspected interference from heterophile antibodies causing a falsely elevated thyroglobulin result.

KETAU | Ketamine and Metabolite Confirmation, Random, Urine

This test is intended for detection and confirmation of ketamine use.

KETAX | Ketamine and Metabolite Confirmation, Chain of Custody, Random, Urine

This test is intended for detection and confirmation of ketamine use, and a chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited.

WGSEQ | Gamma-Globin Full Gene Sequencing, Varies

This test is intended for an adjunct in the interpretation of hemoglobin electrophoresis results. Evaluation for suspected gamma variants or nondeletional hereditary persistence of fetal hemoglobin (HPFH). Assessment of unstable gamma chain variants when other tests for causes of hemolysis are unrevealing).

ALCU | Aluminum/Creatinine Ratio, Urine

This test is intended for measurement of aluminum concentration as a part of aluminum exposure.

ALUCR | Aluminum/Creatinine Ratio, Random, Urine

This test is intended for monitoring aluminum exposure when a 24-hour urine cannot be collected. Monitoring metallic prosthetic implant wear when a 24-hour urine cannot be collected. This test is not an acceptable substitute for serum aluminum measurements and is not recommended for routine aluminum screening.

In addition to these tests, the department also announced several test changes. Click the links below to view test changes announced by Mayo Clinic Laboratories:

Chantell Canfield (@chantellcanfield)

Chantell Canfield

Chantell Canfield is a web content coordinator for Mayo Clinic Laboratories. She began working for Mayo Clinic in 2021.