Histology – Page 8 – ScanLab Center

06 Jun

HPV DNA DETECTION & TYPING

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Human Papilloma Virus Detection & Typing; High Risk Hpv.

Abbreviations

HPV DNA

^Type

Profile/ Panel (Bundled Tests)

^Results

RESULTS READY WITHIN 10 DAYS

^Method

PCR

^Temp

ROOM TEMPERATURE (14 DAYS), 2-8ºC (14 DAYS)

^Setup

BATCHED

Components Parameters

Testing For Multiple High Risk Hpv Types.

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY EXACT SPECIMEN TYPE/ SOURCE.

Patient preparation

IN CASE OF SELF SAMPLING, MANUFACTURER'S INSTRUCTIONS FOR SELF COLLECTED SPECIMENS APPLY.

Sample type

VARIABLE I.E. SWABS (E.G. VAGINAL, ENDOCERVICAL, RECTAL), CERVICAL CELLS IN LIQUID BASED CYTOLOGY (LBC) VIAL OR OTHER ACCEPTABLE MEDIA ETC. (REFER TO MANUFACTURER'S INSTRUCTIONS IF IN DOUBT).

Container/ preservative

ENTIRE LBC VIAL OR APPROPRIATE SWAB IN TRANSPORT TUBE.

Sample volume

- N/A

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NEGATIVE FOR SPECIFIED HIGH RISK GENOTYPES E.G. 16, 18 ETC.

Clinical Utility

HPV IS A COMMON SEXUALLY TRANSMITTED INFECTION (STI). HIGH RISK HPV GENOTYPES (E.G. 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) ARE ASSOCIATED WITH DYSPLASIA (PRE-MALIGNANT) & NEOPLASIA (CANCER) OF THE CERVIX. THEY ARE ALSO ASSOCIATED WITH OTHER MALIGNANCIES E.G. SOME PENILE, ANAL CANCERS ETC. HPV DETECTION IS A SCREENING STRATEGY FOR CERVICAL CANCER.

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE PREVENTS DNA AMPLIFICATION FOR HPV DETECTION.

06 Jun

HIV-1 QUALITATIVE PCR

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Disease

Synonym/Aliases

Hiv-1 Rna Detection

Abbreviations

- N/A

^Type

Individual Test

^Results

RESULTS READY WITHIN 7 DAYS

^Method

REAL TIME PCR

^Temp

REFRIGERATED (2-8ºC) OR FROZEN (-20ºC) EDTA PLASMA.

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY SAMPLE TYPE

Patient preparation

- N/A

Sample type

EDTA PLASMA (CENTRIFUGE & SEPARATE PLASMA FROM WHOLE BLOOD WITHIN 2 HOURS.

Container/ preservative

EDTA

Sample volume

2-3 ML EDTA PLASMA

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE

Clinical Utility

DIAGNOSIS OF HIV 1 INFECTION

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT NUCLEIC ACID AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION.

06 Jun

HIV 1 PROVIRAL DNA (QUALITATIVE PCR)

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Disease

Synonym/Aliases

- N/A

Abbreviations

- N/A

^Type

Individual Test

^Results

RESULTS READY WITHIN 5 DAYS

^Method

REAL TIME PCR

^Temp

ROOM TEMPERATURE 2 DAYS, 2-8ºC

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY

Patient preparation

- N/A

Sample type

EDTA WHOLE BLOOD

Container/ preservative

FORMALIN FIXED, PARAFFIN EMBEDDED BLOCKS [PREFERRED]. ALTERNATIVELY, 4-5 MICRONS UNSTAINED SECTIONS ON POSITIVELY-CHARGED SLIDES (≥FOUR SLIDES).

Sample volume

3 ML

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NEGATIVE

Clinical Utility

PRIMARILY USED IN EARLY INFANT DIAGNOSIS (EID) OF HIV-1 INFECTION I.E. DIAGNOSING HIV 1 INFECTION IN HIV-1 EXPOSED CHILDREN AGED 18 MONTHS (BORN TO HIV 1 POSITIVE MOTHERS).

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT NUCLEIC ACID AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION.

06 Jun

HER2, FISH

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Oncology (Solid Tymors)

Synonym/Aliases

Human Epidermal Growth Factor Receptor 2 (Her2) Fish. Her2/neu, Fish; C-erbb2, Fish; Erbb2, Fish; Hercept Test, Fish.

Abbreviations

HER2

^Type

Individual Test

^Results

RESULTS READY WITHIN 7 DAYS

^Method

FLUORESCENT IN SITU HYBRIDIZATION (FISH)

^Temp

ROOM TEMPRATURE

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. CLINICAL HISTORY, HISTOLOGY (H&E) REPORT ARE MANDATORY.

Patient preparation

- N/A

Sample type

TUMOR POSITIVE FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BLOCK.

Container/ preservative

FORMALIN FIXED, PARAFFIN EMBEDDED BLOCKS [PREFERRED]. ALTERNATIVELY, 4-5 MICRONS UNSTAINED SECTIONS ON POSITIVELY-CHARGED SLIDES (≥FOUR SLIDES).

Sample volume

SUFFICIENT RESIDUAL TISSUE/ TUMOR MUST BE AVAILABLE ON THE BLOCK

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

INTERPRETIVE DATA IS PROVIDED ON THE REPORT.

Clinical Utility

THERANOSTIC MARKER FOR BREAST CANCER I.E. PREDICTS RESPONSE TO HER2 TARGETED THERAPY E.G. TRASTUZUMAB (HERCEPTIN), PERTUZUMAB, LAPATINIB. HER2 TESTING USING FLUORESCENT IN SITU HYBRIDIZATION (FISH) IS INDICATED FOR SAMPLES WITH EQUIVOCAL (2+) HER2 RESULTS ON IHC.

Test Limitations/ Confounders

FOR OPTIMAL RESULTS, THE WET TISSUE (PRIMARY SPECIMEN) SHOULD BE FIXED IN 10% NEUTRAL BUFFERED FORMALIN WITHIN 30 MINUTES OF REMOVAL FROM THE PATIENT AND THE DURATION OF FIXATION SHOULD BE WITHIN 6-72 HOURS (I.E. NOT LESS THAN 6 HOURS AND NOT MORE THAN 72 HOURS).

06 Jun

HEPATITIS C VIRAL LOAD (QUANTITATIVE)

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Hcv Rna Quantitation; Hcv Quantitative Pcr; Hcv Viral Load; Hcv Nucleic Acid Test (Nat); Hcv Nucleic Acid Amplification Test (Naat).

Abbreviations

HCV RNA; HCV VL; HCV NAT; HCV NAAT

^Type

Individual Test

^Results

RESULTS READY WITHIN 10 DAYS

^Method

PCR

^Temp

REFRIGERATED, 2-8ºC (3 DAYS); FROZEN (>30 DAYS; EDTA PLASMA OR SERUM).

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY SAMPLE TYPE. SPECIFY EXACT HCV NAT/ HCV PCR TYPE I.E. QUALITATIVE (FOR DIAGNOSIS) OR QUANTITATIVE (FOR TREATMENT MONITORING IN PATIENTS IN WHOM DIAGNOSIS HAS ALREADY BEEN ESTABLISHED).

Patient preparation

- N/A

Sample type

VARIABLE E.G. EDTA PLASMA/ SERUM

Container/ preservative

EDTA PLASMA IN SEPARATION VIAL, EDTA WHOLE BLOOD IN PLASMA SEPARATION TUBE (PST), SERUM SEPARATOR TUBE (SST).

Sample volume

5 ML EDTA WHOLE BLOOD OR 2ML EDTA PLASMA/ SERUM.

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE

Clinical Utility

MONITOR VIRAL LOAD & TREATMENT RESPONSE IN CHRONIC HCV INFECTION

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT NUCLEIC ACID AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION.

06 Jun

HCV RNA (QUALITATIVE PCR)

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Hepatitis C Virus Qualitative Pcr; Hcv Nucleic Acid Test (NAT); HCV Nucleic Acid Amplification Test (NAAT).

Abbreviations

HCV RNA; HCV NAT; HCV NAAT

^Type

Individual Test

^Results

RESULTS READY WITHIN 10 DAYS

^Method

SEQUENCING

^Temp

REFRIGERATED, 2-8ºC (3 DAYS); FROZEN (>30 DAYS; EDTA PLASMA OR SERUM).

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

Patient preparation

- N/A

Sample type

VARIABLE E.G. EDTA PLASMA/ SERUM

Container/ preservative

EDTA PLASMA IN SEPARATION VIAL, EDTA WHOLE BLOOD IN PLASMA SEPARATION TUBE (PST), SERUM SEPARATOR TUBE (SST).

Sample volume

5 ML EDTA WHOLE BLOOD OR 2ML EDTA PLASMA/ SERUM.

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE

Clinical Utility

TO DIAGNOSE ACTIVE OR CHRONIC HEPATITIS C VIRUS (HCV) INFECTION.

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT NUCLEIC ACID AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION.

06 Jun

HEPATITIS C VIRUS, GENOTYPE

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Biology

Sub Category

Infectious Diseases

Synonym/Aliases

- N/A

Abbreviations

HCV GENOTYPE

^Type

Individual Test

^Results

RESULTS READY WITHIN 14 DAYS

^Method

SEQUENCING

^Temp

ROOM TEMPERATURE 1DAY, 2-8ºC 1 DAY, FROZEN 30 DAYS

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY SAMPLE TYPE.

Patient preparation

- N/A

Sample type

EDTA PLASMA, SERUM

Container/ preservative

EDTA, SERUM SEPARATOR TUBE (SST)

Sample volume

- N/A

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE; CLOTTED SAMPLE.

Other Instructions

- N/A

Reference intervals

NEGATIVE

Clinical Utility

USEFUL IN PREDICTING RESPONSE TO THERAPY

Test Limitations/ Confounders

- N/A

06 Jun

HEPATITIS B VIRAL LOAD (QUANTITATIVE)

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Hbv Dna Quantitation; Hbv Quantitative PCR

Abbreviations

HBV DNA; HBV VL

^Type

Individual Test

^Results

RESULTS READY WITHIN 10 DAYS

^Method

PCR

^Temp

REFRIGERATED, 2-8ºC (7 DAYS); FROZEN (>30 DAYS)

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY SAMPLE TYPE.

Patient preparation

- N/A

Sample type

VARIABLE E.G. EDTA PLASMA/ SERUM

Container/ preservative

EDTA PLASMA IN SEPARATION VIAL, EDTA WHOLE BLOOD IN PLASMA SEPARATION TUBE (PST), SERUM SEPARATOR TUBE (SST).

Sample volume

5 ML EDTA WHOLE BLOOD OR 2ML EDTA PLASMA/ SERUM

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE

Clinical Utility

MONITOR VIRAL LOAD & TREATMENT RESPONSE IN CHRONIC HBV INFECTION

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT DNA AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION

06 Jun

HBV DNA (QUALITATIVE PCR)

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Hepatitis B Virus Qualitative Pcr

Abbreviations

HBV DNA

^Type

Individual Test

^Results

RESULTS READY WITHIN 10 DAYS

^Method

PCR

^Temp

REFRIGERATED, 2-8ºC (7 DAYS); FROZEN (>30 DAYS)

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY SAMPLE TYPE.

Patient preparation

- N/A

Sample type

VARIABLE E.G. EDTA PLASMA/ SERUM

Container/ preservative

EDTA PLASMA IN SEPARATION VIAL, EDTA WHOLE BLOOD IN PLASMA SEPARATION TUBE (PST), SERUM SEPARATOR TUBE (SST).

Sample volume

5 ML EDTA WHOLE BLOOD OR 2ML EDTA PLASMA/ SERUM

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE

Clinical Utility

TO DIAGNOSE HEPATITIS B VIRUS INFECTION E.G. IN PATIENTS WITH INCONCLUSIVE SEROLOGY RESULTS. IF DETECTABLE FOR MORE THAN 6 MONTHS, THIS IS CONSISTENT WITH CHRONIC HBV INFECTION.

Test Limitations/ Confounders

PRESENCE OF PCR INHIBITORS IN THE SAMPLE MAY PREVENT DNA AMPLIFICATION. PARADOXICAL RESULTS MAY ARISE DUE TO SELECTION OF INAPPROPRIATE SPECIMEN AND CONTAMINATION DURING SPECIMEN COLLECTION

06 Jun

GENEXPERT, TB PCR

June 6, 2023June 6, 2023vincentochiengde

Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Genexpert, Tb/rif Pcr; Genexpert Tb/rif Ultra Pcr

Abbreviations

TB PCR; TB/RIF PCR

^Type

Profile/ Panel (Bundled Tests)

^Results

RESULTS READY WITHIN 24-48 HOURS.

^Method

AUTOMATED REAL TIME PCR

^Temp

ROOM TEMPERATURE (3 DAYS), 2-8ºC (7 DAYS).

^Setup

BATCHED

Components Parameters

M. Tuberculosis Complex, Rifampicin Resistance As Applicable.

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY EXACT SAMPLE TYPE.

Patient preparation

PATIENT INSTRUCTIONS SHOULD BE PROVIDED FOR SPUTUM COLLECTION (SALIVA SHOULD NOT BE SUBMITTED)

Sample type

VARIABLE DEPENDING ON SUSPECTED SITE OF INFECTION E.G. PULMONARY (SPUTUM, BRONCHOALVEOLAR LAVAGE. STOOL OR GASTRIC ASPIRATE FOR <5 YEAR OLDS UNABLE TO EXPECTORATE SPUTUM); PLEURAL (PLEURAL BIOPSY, PLEURAL FLUID); GASTROINTESTINAL (ASCITIC/ PERITONEAL FLUID, TISSUE BIOPSY), LYMPH NODES (BIOPSY OR ASPIRATE), CENTRAL NERVOUS SYSTEM (CSF), MUSCULOSKELETAL (SYNOVIAL FLUID, PUS, TISSUE) ETC.

Container/ preservative

STERILE, LEAK PROOF, PLASTIC CONTAINER

Sample volume

3 ML/ 1x1CM TISSUE

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE; BLOOD STAINED SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE FOR MYCOBACTERIUM TUBERCULOSIS.

Clinical Utility

DETECTION OF MYCOBACTERIUM TUBERCULOSIS & RIFAMPICIN RESISTANCE. THE LATTER IS USED AS AN INDICATOR OF POSSIBLE MULTI DRUG RESISTANT TUBERCULOSIS.

Test Limitations/ Confounders

- N/A

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