New tests launched in December


New Tests

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

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

RPTU1 | Protein/Creatinine Ratio, Random, Urine

This test is intended for evaluation of renal disease, screening for monoclonal gammopathy

ETGSR | Ethyl Glucuronide Screen with Reflex, Random, Urine

This test is intended for screening for drug abuse involving alcohol.

CSMEU | Controlled Substance Monitoring Enhanced Profile with Reflex, 21 Drug Classes, High Resolution Mass Spectrometry and Immunoassay Screen, Random, Urine

This test is intended for detecting drug use involving stimulants, barbiturate, benzodiazepines, cocaine, opioids, tetrahydrocannabinol, and alcohol. This test is not intended for use in employment-related testing.

FBL | Fungal Culture, Blood

This test is intended for diagnosis and treatment of the etiologic agents of fungemia. Select patient population that presents with signs and symptoms of sepsis, especially fever of unknown origin.

EOSMF | Chronic Eosinophilia, Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement (including PDGFRAPDGFRB, FGFR1, JAK2, and ABL1) using specified probes set. Supporting a diagnosis of malignancy, when a clone is present, an adjunct to conventional chromosome studies.

EOSDF | Chronic Eosinophilia, Diagnostic FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement (including PDGFRA, PDGFRB, FGFR1, JAK2, and ABL1). Supporting the diagnosis of malignancy if a clone is present, an adjunct to conventional chromosome studies.

PHLDF | Philadelphia Chromosome-like Acute Lymphoblastic Leukemia (Ph-like ALL), Diagnostic FISH, Varies

This test is intended for detecting a neoplastic clone associated with Philadelphia chromosome-like acute lymphoblastic leukemia, particularly when a classic abnormality is not detected with the initial panel, an adjunct to conventional chromosome studies in patients with B-cell ALL. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

HEMMF | Gadolinium/Creatinine Ratio, Urine

This test is intended for the detection of specific chromosomal abnormalities in hematologic malignancies.

TALPF | T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements seen in pediatric/young adult patients with T-cell acute lymphoblastic leukemia (T-ALL), an adjunct to conventional chromosome studies in patients with T-ALL. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

BLPMF | B-Cell Lymphoma, Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with various B-cell lymphomas, tracking known chromosome abnormalities and response to therapy in patients with B-cell lymphoma. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

BALAF | B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements seen in adult patients with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL). An adjunct to conventional chromosome studies in patients with B-ALL/LBL, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

TALMF | T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements observed in patients with T-cell acute lymphoblastic leukemia (T-ALL) using client specified probes, an adjunct to conventional chromosome studies in patients with T-ALL. Evaluating specimens in which standard cytogenetic analysis is unsuccessful, identifying and tracking known chromosome abnormalities in patients with T-ALL and monitoring response to therapy.

BALPF | B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Pediatric, FISH, Varies

This test is intended for evaluation of pediatric bone marrow and peripheral blood specimens by fluorescence in situ hybridization probe analysis for classic rearrangements and chromosomal copy number changes associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL) and Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL). As an adjunct to conventional chromosome studies in performed in pediatric patients with B-ALL and Ph-like ALL, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

BALMF | B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements seen in patients with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) using client specified probes, an adjunct to conventional chromosome studies in patients with B-ALL/LBL, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

CILPF | Congenital Infantile Leukemia, FISH, Tissue

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements seen in infant patients with leukemia using tissue specimens.

BLBLF | B-Cell Lymphoblastic Leukemia/Lymphoma, FISH, Tissue

This test is intended for detecting a neoplastic clone in paraffin embedded specimens associated with the common chromosome abnormalities seen in patients with B-cell lymphoblastic leukemia/lymphoma.

TLPDF | T-Cell Lymphoma, Diagnostic FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities observed in patients with various T-cell lymphomas using a laboratory-designated probe set algorithm, tracking known chromosome abnormalities and response to therapy in patients with T-cell lymphoma, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

AMLPF | Acute Myeloid Leukemia (AML), FISH, Pediatric, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements seen in pediatric/young adult patients with acute myeloid leukemia (AML), an adjunct to conventional chromosome studies in patients with AML. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

MFCDF | Myeloma, High Risk with Reflex Probes, Diagnostic FISH Evaluation, Fixed Cell Pellet

This test is intended for aiding in the diagnosis of new cases of multiple myeloma or other plasma cell proliferative disorders using a fixed cell pellet derived from bone marrow, identifying prognostic markers based on the abnormalities found. This test should not be used to track the progression of disease.

AMLMF | Acute Myeloid Leukemia (AML), Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the recurrent chromosome abnormalities seen in patients with acute myeloid leukemia (AML) or other myeloid malignancies using a client specified probe set, an adjunct to conventional chromosome studies in patients with AML, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

AMLAF | Acute Myeloid Leukemia (AML), FISH, Adult, Varies

This test is intended for detecting a neoplastic clone associated with recurrent chromosome abnormalities seen in adult patients with acute myeloid leukemia (AML) or other myeloid malignancies, an adjunct to conventional chromosome studies in patients with AML, evaluating specimens in which standard cytogenetic analysis is unsuccessful.

TALAF | T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements observed in adult patients with T-cell acute lymphoblastic leukemia (T-ALL), an adjunct to conventional chromosome studies in patients with T-ALL. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

TLPMF | T-Cell Lymphoma, Specified FISH, Varies

This test is intended for detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with various T-cell lymphomas using client specified probes, tracking known chromosome abnormalities and response to therapy in patients with T-cell lymphoma. Evaluating specimens in which standard cytogenetic analysis is unsuccessful.

FIERA | IgE Receptor Antibody

This test is intended for the test detects functional autoantibodies to the Fc-epsilon receptor (high affinity IgE receptor) or to IgE and is useful in the evaluation of chronic urticaria.

TLUCR | Thallium/Creatinine Ratio, Random, Urine

This test is intended for detecting toxic thallium exposure in random urine specimens.

HBRP | Histoplasma capsulatum/Blastomyces species, Molecular Detection, PCR, Varies

This test is intended for rapid detection of Histoplasma capsulatum and Blastomyces dermatitidis DNA, an aid in the rapid diagnosis of histoplasmosis and blastomycosis.

ATPCO | Anal ThinPrep Cytology with Human Papillomavirus (HPV) Co-Test, Varies

This test is intended for detection of malignant and premalignant changes, detection of high-risk (HR) genotypes associated with the development of anal cancer, individual genotyping of human papillomavirus (HPV)-16 and HPV-18, if present. May aid in triaging men and women with positive HR-HPV but negative anal Pap smear results. The cobas HPV test is not recommended for evaluation of suspected sexual abuse.

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.