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The master copy and approval record for this document are held within Q-Pulse. If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list. INTEGRATED PATHOLOGY SERVICE GENERAL PATHOLOGY DOCUMENT Chemistry Test User Guide A-E [PD-CHM-TestGuide1] AUTHOR: Samantha Nelson APPROVED BY: Steve Short DATE OF ISSUE: 20/09/2019 DATE EFFECTIVE FROM: 20/09/2019 VERSION NO: 1 REVIEW INTERVAL: Biennial COPY: 1 LOCATION OF COPIES: 1 Electronic – Q-Pulse 2 Electronic - StaffNet Page 1 of 95 Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1 Approved by Steve Short – Review Period: Biennial Author(s): Samantha Nelson

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Page 1:  · Web viewThe master copy and approval record for this document are held within Q-Pulse. If printed, this is a controlled document ONLY if printed on cream coloured paper and shown

The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

INTEGRATED PATHOLOGY SERVICEGENERAL PATHOLOGY DOCUMENT

Chemistry Test User GuideA-E

[PD-CHM-TestGuide1]

AUTHOR: Samantha NelsonAPPROVED BY: Steve ShortDATE OF ISSUE: 20/09/2019DATE EFFECTIVE FROM: 20/09/2019VERSION NO: 1REVIEW INTERVAL: BiennialCOPY: 1LOCATION OF COPIES: 1 Electronic – Q-Pulse

2 Electronic - StaffNet

Page 1 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Acetylcholine receptor antibodySynonyms ACRA, ACHRSample type Gold topTest instructionsReferral laboratory Immunology department

Churchill hospitalHeadingtonOxfordOX3 7LJ

Turnaround time 2 WeeksTest indications Acetylcholine receptor antibodies are a

highly sensitive and specific marker for generalised myasthenia gravis. Present in 90% of patients with myasthenia gravis

Reference intervals Negative is <5 X10-10 mole per litreInterferences

Page 2 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay AcylcarnitinesSynonyms Total carnitines, metabolicSample type Blood spot (Guthrie card)Test instructions Bloodspot card. Two > 7mm diameter

bloodspots. Blood must be soaked through and not multi-spotted

Referral laboratory Inherited Metabolic Diseases Unit at St Thomas' Hospital0207 188 9652St Thomas' Hospital North Wing4th Floor LondonSE1 7EH

Turnaround time 10 daysTest indications Used in the investigation of fatty chain

oxidationReference intervals Contact referral laboratory to discussInterferences

Page 3 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Adrenocorticotrophic hormone (ACTH)

Synonyms ACTHSample type EDTA Plasma (350 uL)Test instructions Must be sent to laboratory ASAP to be

spun and frozen.Referral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondonSE5 9RS

Turnaround times 7-10 daysTest indications Used in the investigation of pituitary-

adrenal disorders relating to glucocorticoids

Reference intervals <46 ng/LInterferences

Page 4 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

Page 5:  · Web viewThe master copy and approval record for this document are held within Q-Pulse. If printed, this is a controlled document ONLY if printed on cream coloured paper and shown

The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Alanine AminotransferaseSynonyms ALTSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Elevated serum ALT is found in hepatitis,

cirrhosis, obstructive jaundice, carcinoma of the liver, and chronic alcohol abuse. ALT is only slightly elevated in patients who have an uncomplicated myocardial infarction.

Reference intervals 5-40 u/LInterferences

Page 5 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay AlbuminSynonymsSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Albumin is a key plasma protein. Low

levels are seen in liver disease, burns, malabsorption, and is losses through the kidneys (proteinuria) and stool. Raised levels usually indicate dehydration. During illness albumin tends to move towards the extravascular compartment; the resulting lowered concentration of albumin is the most common change in plasma proteins in pathological stress.-Concentrations less than 30 g/L usually signify serious organic disease-The lowest values (10-20 g/L) occur in nephrotic syndrome and protein losing enteropathy-Concentrations below 20 g/L are generally accompanied by oedema.

Reference intervals < 11 months: 30-45 g/L, 11 months- 15 years: 30-50 g/L, > 15: 35-50 g/L

Interferences

Page 6 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Aldosterone and ReninSynonyms Aldosterone, Renin, PRA, ALDOSample type EDTA Plasma (Purple top)Test instructions Must be sent to laboratory ASAP to be

spun and frozen.Referral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondonSE5 9RS

Turnaround time 7-10 daysTest indications Used in the investigation of suspected

disorders of the adrenal glands. Recommended on an outpatient basis for the diagnosis of Conn’s syndrome.

Reference intervals Renin (mU/L): Upright 5.4 - 60, Supine 5.4 - 30

Aldosterone (pmol/L): Upright 100 - 800, Supine 100 - 450

Aldo/Renin ratio: <80: Conn’s unlikely, >/=200: Conn’s likely, 80-200: Conn’s not excluded

Interferences Most hypertensives

Page 7 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Alkaline phosphateSynonyms ALP, ALKPSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications A rise in the alkaline phosphatase occurs

with all forms of cholestasis, particularly with obstructive jaundice. It is also elevated in diseases of the skeletal system, such as Pagets disease, hyperparathyroidism, rickets and osteomalaecia, as well as with fractures and malignant tumours. A considerable rise in the alkaline phosphatase activity is sometimes seen in children and juveniles. It is caused by increased osteoblast activity following accelerated bone growth.

Reference intervals < 4 weeks: 70-380 u/L, 4 weeks- 15 years: 60-425 u/L, > 15 years: 30-130 u/L

Interferences

Page 8 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Alkaline phosphate isoenzymeSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Immunochemistry Laboratory at King's

College Hospital020 3299 4130King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 1-2 weeksTest indications Used to distinguish between bone and

liver origin of elevated alkaline phosphatase. However gamma glutamyl transferase (GGT) which is performed daily in the laboratory can usually give the same information more quickly since gamma GT is not present in the bone.

Reference intervals Contact referral laboratoryInterferences

Page 9 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Alpha-1-antitrypsinSynonyms A1AT, AATSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround time

Test indications A1AT levels are primarily used when assessing a diagnosis of acute hereditary A1AT deficiency as a cause of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood, orwhen severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.Samples with low AAT levels are referred for A1AT phenotyping to exclude hereditary A1AT deficiencies

Reference intervals < 52 weeks: 0.9-1.8 g/L, 52 weeks- 15 years: 1.1-2.1 g/L, > 15 years: 2.2-2.6 g/L.

Interferences

Page 10 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Alpha-fetoproteinSynonyms AFPSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications AFP is an albumin like glycoprotein. AFP

is used as a tumour marker for germ cell/testicular tumours and hepatocellular carcinomas.Also raised in other cancers (colorectal, gastric, lung, pulmonary) and some benign conditions (liver regeneration). It is found in high concentrations in foetal serum and in very low concentrations in normal adult serum (<10 iu/mL) but may range from normal to very high levels (>100,000 iu/mL) in the sera of patients with hepatocellular or yolk-sac derived (endodermal sinus) cancers. Elevations up to 500 iu/mL frequently occur in association with a variety of non-malignant liver diseases, but levels above this are suugestive of an AFP producing tumour. However, a significant number of tumours have a normal AFP at diagnosis. In benign disease AFP elevation is either constant or transient. In pregnancy maternal serum levels may be used to assess the risk of neural tube defects and Down syndrome (when combined with other markers)

Reference intervals <9 iu/mLInterferences

Page 11 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay AluminiumSynonymsSample type SST (Gold top)Test instructions Volume required: 500µlReferral laboratory Trace Elements Laboratory at King's

College Hospital020 3299 3008King's College Hospital Bessemer Wing –Top Floor Denmark Hill London SE5 9RS

Turnaround time 1- 2 weeksTest indications Used in the investigation of aluminium

toxicityReference intervals Normal serum aluminium concentration

is < 0.4 µmol/L in subjects with no history of chronic renal failure (CRF). It is however, common for concentrations to be above >0.4µmol/L in renal patients

Interferences

Page 12 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Amino Acid (Plasma)Synonyms Metabolic screenSample type Lithium heparin plasmaTest instructions Minimum sample volume 500 uL plasma.

Lipaemic samples are unsuitable.Referral laboratory Inherited Metabolic Diseases Unit at St

Thomas' Hospital0207 188 9652St Thomas' HospitalNorth Wing - 4th FloorLondonSE1 7EH

Turnaround time 1-2 weeksTest indications Used in the investigation of amino acid

disorders, including urea cycle defects and some organic acid disorders.

Reference intervals Contact referral laboratoryInterferences

Page 13 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Amino acids (Urine)SynonymsSample type Random urine, universal white topTest instructions Minimum sample volume 2 mL urine.

Acidified samples are unsuitable.Referral laboratory Inherited Metabolic Diseases Unit at St

Thomas' Hospital0207 188 9652St Thomas' HospitalNorth Wing - 4th FloorLondonSE1 7EH

Turnaround time 2 weeksTest indications Urine amino acids is no longer used as a

metabolic screen (please use plasma amino acids). It is available for the investigation of renal transport disorders (e.g. cystinuria), the assessment of renal tubular dysfunction (e.g. Fanconi syndrome, mitochondrial disease) and for some other specific disorders (e.g. hypophosphatasia).

Reference intervals Qualitative reportInterferences

Page 14 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay AmiodaroneSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Toxicology Laboratory 

The Academic Centre Llandough Hospital Penarth CF64 2XXTel: 029 2071 6894

Turnaround time 6 weeksTest indications Used in the therapeutic drug monitoring

of amiodaroneReference intervals Contact referral laboratoryInterferences

Page 15 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay AmmoniaSynonyms NH3Sample type Lithium heparin (Green top)Test instructions Must be brought to the laboratory ASAP

on ice.Referral laboratory N/ATurnaround timeTest indications Used in the diagnosis and monitoring of

urea cycle disorders and Reyes syndrome

Reference intervals <4 weeks: <100 umol/L, >4 weeks: <50 umol/L

Interferences

Page 16 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Amylase (Serum)Synonyms AmySample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Because of the scarcity of specific clinical

symptoms of pancreatic diseases, amylase determinations are of considerable importance in pancreatic diagnostics. They are mainly used in the diagnosis and monitoring of acute pancreatitis. Very high levels support the diagnosis of pancreatitis. However other conditions which present with abdominal pain may have very elevated levels: Afferent loop obstruction, absorption through the peritoneum as in biliary peritonitis, damage to the pancreas or its blood supply. Hyperamylasaemia does not, however, only occur with acute pancreatitis or in the inflammatory phase of chronic pancreatitis, but also in renal failure (reduced glomerular filtration), tumours of the lungs or ovaries, pulmonary inflammation, diseases of the salivary gland, diabetic ketoacidosis, cerebral trauma, surgical interventions or in the case of macroamylasaemia

Reference intervals <14 days: 3-10 iu/L, 14 days to 14 weeks: 2 -22 iu/L, 14 weeks to 1 year: 3-50 iu/L, 1 year- 19 years: 25-101 iu/L, >19 years: 25-101 iu/L

Interferences

Page 17 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Amylase (Urine)SynonymsSample type Random urine sample in universal

containerTest instructions N/AReferral laboratory N/ATurnaround timeTest indications Used in the investigation of raised serum

amylase activity, to exclude macroamylasaemia

Reference intervals u/LInterferences

Page 18 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay AndrostenedioneSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Clinical Biochemistry - Blood Sciences at

King's College Hospital020 3299 4126King's College HospitalBessemer WingDenmark HillLondon SE5 9RS

Turnaround time 14 working daysTest indications Used in the investigation of

endocrinology disordersReference intervals Adult Females: 1.4 – 14.3 nmol/L

Adult Males: 1.4 – 9.1 nmol/L

Interferences

Page 19 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Angiotensin converting enzymeSynonyms ACESample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Useful for monitoring the activity of

sarcoidosis but not sensitive enough to be used in diagnosis.

Reference intervals 20-70 u/LInterferences

Page 20 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay ArsenicSynonymsSample type EDTA (Purple top) or 24 hour urine in

acid washed bottleTest instructions 4 mL EDTA whole blood or 20 mL urineReferral laboratory Trace Elements Laboratory at King's

College Hospital020 3299 3008King's College HospitalBessemer Wing - Top FloorDenmark HillLondonSE5 9RS

Turnaround time 7-10 working daysTest indications Used in the investigation of arsenic

poisoningReference intervals Blood < 0.13 µmol/L

Urine < 0.13 µmol/24 h (Inorganic arsenic)

Interferences

Page 21 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Aspartate transaminaseSynonyms ASTSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications The enzyme aspartate aminotransferase

(AST) is widely distributed in tissues, principally: hepatic, cardiac, muscle, and kidney. Elevated serum levels are found in diseases involving these tissues

Reference intervals 5-40 u/LInterferences

Page 22 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay AdalimumabSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Reference Chemistry Laboratory at St

Thomas'0207 188 12644th floor, North WingSt Thomas' HospitalWestminster Bridge RoadLondon SE1 7EH

Turnaround time 2 WeeksTest indications The measurement of Adalimumab is a

useful tool in managing patients who fail to respond (primary failure) or who go on to lose response (secondary failure) to treatment. Monitoring drug levels allows for a personalised approach to drug optimisation by appropriate dose escalation/de-escalation or drug switching/withdrawal.

Measured alone or as part of a profile including anti-Adalimumab antibodies.

Reference intervals Lower limit of the therapeutic range is yet to be established, however levels of greater than 5 µg/mL appear to be adequate. This information will be updated as we refine the therapeutic range. Test interpretation requires full

Page 23 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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clinical information: drug dosage/frequency, previous exposure to other biologics, time of sampling, duration of therapy and clinical assessment.

Interferences

Assay BicarbonateSynonyms CO2Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Used in the diagnosis and treatment of

many disorders that are associated with acid-base imbalance in metabolic and respiratory systems.

Reference intervals < 15 years: 19-28 mmol/L , > 15 years: 22-29

Interferences

Page 24 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Bile acidsSynonyms BASample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Serum total bile acids is used as an

indicator of intra-hepatic cholestasis in pregnancy. When the bile flow is stopped or slowed down, this causes a build up of bile acids in the liver which can spill into the bloodstream, and leads to significantly increased serum BA levels.

Reference intervals <10 umol/LInterferences

Page 25 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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The master copy and approval record for this document are held within Q-Pulse.If printed, this is a controlled document ONLY if printed on cream coloured paper and shown within the copy list.

Assay Bilirubin (Total)Synonyms TBIL, LFTSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Total bilirubin forms part of routine liver

screen. Unconjugated bilirubin can increase in circulation when a disease or a conditions produces bilirubin faster than the liver can metabolise it. Bile duct obstruction or damage to hepatocellular structure causes increases of both conjugated and unconjugated bilirubin in circulation.

Reference intervals <1 year: 1-12 umol/L,1-9 years: 1-7 umol/L,9-12 years: 1-9 umol/L12-15 years: 2-12 umol/L15-19 years: 2-14 ummol/L>19 years: 2-21 umol/L

InterferencesComment In the absence of abnormal LFTS a

conjugated/ total bilirubin ratio <0.3 most likely represents Gilbert's syndrome.

Page 26 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay BiotinidaseSynonymsSample type Lithium heparin (Green top)Test instructionsReferral laboratory CardiffTurnaround timeTest indications Used in the investigation of biotinidase

deficiency, which may cause seizuresReference intervals Contact referral laboratoryInterferences

Page 27 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay Brain natriuretic peptideSynonyms BNPSample type EDTA (Pink top)Test instructions Must be analysed within 4 hoursReferral laboratory N/ATurnaround timeTest indicationsReference intervals <100 ng/LInterferences

Page 28 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay C1 Esterase inhibitorSynonyms C1ESample type SST (Gold top)Test instructions N/AReferral laboratory Sheffield immunology & Protein

reference unitDepartment of ImmunologyPO Box 894SheffieldS5 7YT

Turnaround time 2 WeeksTest indications Used for the diagnosis of angioneurotic

oedema.Reference intervals C1 esterase inhibitor: 0.15-0.35 g/L

C1 esterase Inhibitor activity: 70-150 %Interferences

Page 29 of 71Blood Sciences Test User Guide [PD-CHM-TestGuide1] – Version 1

Approved by Steve Short – Review Period: BiennialAuthor(s): Samantha Nelson

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Assay CA 19-9Synonyms CA199Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Cancer antigen 19-9 (CA19-9) is neither

a tumour-specific nor organ-specified antigen. Its main diagnostic relevance is in the diagnosis, monitoring and detection of recurrence of patients with pancreatic, hepato-biliary and gastric cancer.

Reference intervals <37 U/mLInterferencesComment Tumour markers are not diagnostic. They

are of use primarily for monitoring treatment or detection of relapse. Normal values do not exclude malignancy.

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Assay CA 125Synonyms CA125Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications This is a tumour marker for ovarian

carcinoma. Moderate elevations may be seen in non-malignant conditions, e.g. pregnancy, menstruation, endometriosis , ascites, cirrhosis, renal failure, acute pancreatitis, peritonitis and in other inflammatory pelvic diseases. High concentrations are more likely to be associated with malignancy. 98% of post-menopausal and 49% of pre-menopausal women with a concentration >70 U/mL have malignant disease. CA125 > 35 U/mL are seen in 50% of patients with

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Stage 1 ovarian carcinoma and over 90% in Stage 2,3 or 4 disease. Increased CA125 also occurs in patients with non-ovarian malignancy; other gynaecological cancer, 50% of all intra-abdominal cancers and in advanced lung and breast cancer.

Reference intervals <35 U/mLInterferencesComment Tumour markers are not diagnostic. They

are of use primarily for monitoring treatment or detection of relapse. Normal values do not exclude malignancy.

Assay C-Reactive proteinSynonyms CRPSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications A sensitive acute phase protein. In

inflammatory bowel disease CRP correlates with relapse, remission and response to therapy. In rheumatology CRP levels correlate with disease activity in rheumatoid arthritis, polyarteritis nodosa, giant cell arteritis and polymyalgia rheumatic. In infectious disease CRP is elevated in bacterial, fungal and parasitic disease. Viral

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infection may also elevate CRP but not to the same degree as with bacteria.

Reference intervals <5 mg/LInterferences

Assay CaeruloplasminSynonyms CAER, CRPMSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Decreased concentrations of

caeruloplasmin occur due to both primary (genetic) and secondary deficiencies. Primary deficiency due to a deletion of the caeruloplasmin gene has been reported. Secondary deficiencies where there is insufficient incorporation of copper into the caeruloplasmin molecule are significantly more common. These

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include the recessive autosomal hepatolenticular degeneration associated with Wilsons disease. As caeruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes (peaking 4-20 days post acute insult).

Reference intervals < 2 months: 0.07-0.24 g/L2-6 months: 0.14-0.33 g/L6 month – 1 year: 0.14-0.39 g/L1-8 years: 0.22-0.43 g/L8-14 years: 0.21-0.40 g/L14-19 years (Male): 0.17-0.35 g/L14-19 years (Female): 0.21-0.43 g/L>19: 0.20-0.60 g/L

Interferences

Assay CalcitoninSynonymsSample type SST (Gold top)Test instructions Must be sent to the laboratory ASAP to

be spun and frozen.Referral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 7-10 Working days

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Test indications Used in the monitoring of tumours of the thyroid medulla

Reference intervals Male: <11.8pg/mL Female: <4.8pg/mL

Interferences

Assay CalciumSynonyms Ca2+Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Serum/plasma calcium concentrations

are used in the investigation and/or monitoring of calcium metabolism disorders. The laboratory reports plasma/serum total calcium and

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corrected calcium. The corrected calcium adjusts the calcium concentration according to the serum albumin concentration (due to the binding of calcium ions to albumin).

Reference intervals 1-19 years: 2.13-2.75 mmol/L,>19 years: 2.30-2.63 mmol/L.

Interferences

Assay Calcium (urine)SynonymsSample type Random urine, Universal containerTest instructions N/AReferral laboratory N/ATurnaround timeTest indications Used in the investigation of renal stone

formation (calculi) and in the investigation of hyper- and

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hypocalcaemiaReference intervals mmol/LInterferences

Assay CarbemazepineSynonymsSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Carbamazepine is an antiepileptic drug

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for the treatment of epilepsy, trigeminal neuralgia, and simple and complex, partial and generalized convulsive seizures in adults. It is effective as a sole agent in treating the above disorders, but can be used in combination with other antiepileptic drugs. Estimation of carbamazepine levels may be useful when establishing a dosage for new patients, monitoring compliance or assessing for toxicity.

Reference intervals 4-12 mg/LInterferences

Assay Carcino embryonic antigenSynonyms CEASample type SST (Gold top)Test instructions N/AReferral laboratory N/A

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Turnaround timeTest indications Has been widely used to aid cancer

diagnosis, but because CEA may be elevated in a number of non-malignant conditions; elevations must be considered suggestive, but not diagnostic , of cancer. CEA has been most useful for monitoring therapeutic efficiency in patients with adenocarcinoma. High levels are highly suggestive of colorectal cancer

Reference intervalsInterferencesComments CEA is not recommended as a screening

test for bowel cancer but very occasionally may have a role in the frail elderly in whom cancer is suspected.

Assay CA 153SynonymsSample type SST (Gold top)

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Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Used to monitor treatment in breast

cancerReference intervals <31 U/mlInterferencesComment Tumour markers are not diagnostic. They

are of use primarily for monitoring treatment or detection of relapse. Normal values do not exclude malignancy.

Assay Chloride

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Synonyms Cl-, U&ESample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Chloride is the principle anion in plasma.

Its measurement is useful in the differential diagnosis of fluid balance disorders, and may be useful in the differential diagnosis of acid-base balance via the estimation of an anion gap

Reference intervals 95-108 mmol/LInterferences

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Assay CholesterolSynonyms CHOL, LIPIDSSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Cholesterol assays are used for

screening for atherosclerotic risk and in the diagnosis and treatment of disorders involving elevated cholesterol levels as well as lipid and lipoprotein metabolic disorders. Cholesterol is reported as a lipid profile alongside triglyceride and HDL-cholesterol, as well as calculated LDL-cholesterol and non-HDL cholesterol.

Reference intervals 2-5 mmol/LInterferencesComment A non HDL cholesterol of 2.5 mmol/L is

equivalent to an LDL cholesterol of 1.8 mmol/L. Aim for at least a 40% reduction in pre-treatment values.If >7.5mmol/L, consider discussion with lipid clinic.

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Assay CholinesteraseSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Pathology Sciences Laboratory

(Blood Sciences and Bristol Genetics)Southmead HospitalWestbury on TrymBristolBS10 5NBTel: 0117 323 6083

Turnaround time 6 weeksTest indications Cholinesterase is measured to detect

increased sensitivity to succinylcholine and to confirm acute organophosphate poisoning.

Reference intervals 3-9 ku/LInterferences

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Assay Chromogranin ASynonymsSample type SST (Gold top)Test instructionsReferral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 2 weeksTest indications Chromagranin A is useful in the

monitoring of gastroenteropancreatic tumours, and follow up of patients with liver metastases. Also a useful marker in lung carcinoids and neuroblastomas. Chromagranin A is the major protein within the catecholamine storage vesicles of adrenal medulla. When catecholamines are released, chromagranin is released. It is also released with polypeptide hormones from other endocrine tissues: pancreatic islet cells, enteroendocrine cells, parathyroid chief cells, thyroid parafollicular C cells, and anterior pituitary cells.

Reference intervals 0.35-4.94 mu/LInterferencesComment Chromogranins are often assayed in

conjunction with other peptides forming part of the "Gut hormone profile" which includes VIP, gastrin, glucagon, pancreatic polypeptide, somatostatin, chromogranin A and B.

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Assay Chromogranin BSynonymsSample type EDTA (Purple top)Test instructionsReferral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 2 WeeksTest indications Neuroendocrine tumoursReference intervals <150InterferencesComment Chromogranins are often assayed in

conjunction with other peptides forming part of the "Gut hormone profile" which includes VIP, gastrin, glucagon, pancreatic polypeptide, somatostatin, chromogranin A and B.

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Assay ClozapineSynonymsSample type EDTA (Purple top)Test instructions 2 mL of EDTA whole bloodReferral laboratory Toxicology Department at King's Hospital

020 3299 [email protected]'s College HospitalBessemer Wing - 3rd FloorDenmark HillLondon SE5 9RS

Turnaround time 2 working daysTest indications Clozapine is an atypical antipsychotic

used to treat schizophrenia resistant to conventional therapy. Because of the risk of agranulocytosis, white blood cell counts (WBC) are monitored weekly in the early stages of therapy and monthly thereafter. It is recommended that therapy is withheld if the WBC is less than 3,500 mm-3 and abandoned if the WBC falls below 3000 mm-3 or the granulocyte count below 1,500 mm-3. Side-effects of clozapine include lethargy, hypersalivation, constipation and somnolence. There is a risk of hypotension and seizure at higher doses. A single dose of 300-400 mg may be life-threatening in a clozapine naïve subject. Clozapine is metabolised by N-demethylation, hydroxylation and N-oxidation. The N-demethylated metabolite, norclozapine, is present in plasma at similar concentrations to the parent compound, but has a longer plasma half-life. Plasma clozapine concentrations of 0.35 mg/L and above have been associated with a good response, with the risk of convulsions increasing above 1.0 mg/L.

Reference intervals 0.35-0.50 mg/LPage 46 of 71

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Interferences

Assay Cobalt and ChromiumSynonymsSample type SST (Gold top)Test instructionsReferral laboratory Trace Elements Laboratory at King's

College Hospital020 3299 3008King's College HospitalBessemer Wing - Top FloorDenmark HillLondon SE5 9RS

Turnaround time 5-7 DaysTest indications Used in the investigation of chromium or

cobalt toxicityReference intervals Cobalt: < 1.7-6.8 nmol/L

Chromium: < 10 nmol/LInterferences

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Assay C3Synonyms Complement, C3/C4Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Lowered values of C3 are indicative of

activation, with additional differentiation being made when determining C4 in tandem. If the C4 level is normal, then activation of the alternative route is likely. Depressed values are observed in a number of inflammatory and infectious diseases. Primary causes are systemic lupus erythematosus (SLE), rheumatoid arthritis, subacute bacterial endocarditis, viremia, parasitic infections or bacterial sepsis. A considerable decrease in C3 can be found in patients with partial lipodystrophy or membranoproliferative glomerulonephritis when the C3-nephritis factor is present. Other causes of deficient C3 is a primary Immune deficiency of complement component (although C3 deficiency is extremely rare). More common genetic causes are C2 deficiency (classical) and deficiency of proteins controlling the alternate pathway including factor H, I and x-linked properdin. Further Immunological investigation must be initiated if suspected. As C3 is an acute phase protein, it is produced to an increased extent during inflammatory processes. It is elevated in systemic infections, non-infectious chronic inflammatory conditions (primarily chronic polyarthritis) and physiological states (pregnancy). The elevation rarely exceeds twice the

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normal value and can mask a reduction in the current consumption.

Reference intervals <14 days: 0.50-1.21 g/L,14 days – 1 year: 0.51-1.60 g/L,1-19 year: 0.83-1.52 g/L,Female >19 years: 0.82-1.93 g/LMale > 19 years: 0.82-1.85

Interferences

Assay C4Synonyms Complement C3/C4Sample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications C4 determinations are indicated when

assessing the course of hypocomplement conditions. C4 deficiency is a hallmark for the following conditions: C1 esterase inhibitor deficiency (which controls the classical pathway) known as Hereditary Angioedema (further investigation into C1IN is needed); cryoglobulaemia. (cryoglobulin testing and hepatitis serology may be indicated); and C4 shares an inverse correlation with anti-dsDNA antibodies in SLE.

Reference intervals <1 year: 0.07-0.30 g/L,1-19 years: 0.13-0.37 g/L,Female >19 years: 0.15-0.57 g/L,Male > 19 years: 0.15-0.53 g/L.

Interferences

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Assay CopperSynonyms CuSample type SST (Gold top)Test instructionsReferral laboratory Trace Elements Laboratory at King's

College Hospital020 3299 3008King's College HospitalBessemer Wing - Top FloorDenmark HillLondon SE5 9RS

Turnaround time 2-4 Working daysTest indications Used in the investigation of disorders of

copper metabolismReference intervals <5 months: 3-11 umol/L

5-6 months: 3.9-17.3 umol/L6-11 months: 7.9-20.5 umol/L>11 months: 12-25 umol/L

Interferences

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Assay CortisolSynonymsSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Cortisol is used to investigate the

hypothalamic- pituitary-adrenal function. It is commonly used to estimate the physiological response to dynamic function tests (e.g. Synacthen stimulation test or dexamethasone suppression test) when a diagnosis of Cushings disease / syndome or Addisons disease is suspected

Reference intervals 150-600 nmol/LInterferencesComment Random cortisols are not generally

useful to exclude Cushing’s or Addison’s

150-600 nmol/l. Reference Range refers to 9am cortisol and assumes established circadian rhythm. In a well patient cortisol levels above 400nmol/L make adrenal insufficiency unlikely. Midnight and post dexamethasone <40nmol/l.

Cortisol increases post synacthen to greater than 480 nmol/L is adequate, between 450-479 nmol/L is equvocal, and less than 450 nmol/L is inadequate.

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Assay Cortisol (Urine)SynonymsSample type 24-hour urine collection in a universal

container.Test instructionsReferral laboratory Immunochemistry Laboratory at King's

College Hospital020 3299 4130King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 3 weeksTest indications Used in the investigation of corticoid

excess, i.e. CushingsReference intervals <200 nmol/24hInterferences

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Assay CreatinineSynonyms CRT, U&ESample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Used in the assessment of renal function,

as a marker of glomerular filtration rate. Serum level has an inverse exponential correlation with GFR. Levels may be in the normal range when GFR has halved.

Reference intervals <14 days: 37-93 umol/L14 days to 1 year: 27-47 umol/L1-4 years: 34-49 umol/L4-7 years: 39-57 umol/L7-12 years: 46-61 umol/L12-15 years: 50-71 umol/LMale 15-17 years: 57-92 umol/LFemale 15-17 years: 52-76 umol/LMale 17-19 years: 61-97 umol/LFemale 17-19 years: 53-78 umol/LMale >19: 64-111Female >19: 50-98 umol/L

Interferences

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Assay Creatinine (Urine)SynonymsSample type Universal white top containerTest instructions Random urineReferral laboratory N/ATurnaround timeTest indications Urine creatinine is used either as a

marker of urine concentration in the assessment of urinary excretion of compounds (e.g. albumin creatinine ratio, etc.) or the 24hr excretion of creatinine can be used (alongside a serum creatinine taken within the collection period) to estimate glomerular filtration rate (creatinine clearance).

Reference intervalsInterferences

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Assay Creatinine clearance (Urine)SynonymsSample type 24 hour urine, universal containerTest instructions N/AReferral laboratory N/ATurnaround timeTest indications Under conditions of normal renal

function, creatinine is excreted by glomerular filtration. Creatinine determinations are performed for the diagnosis and monitoring of acute and chronic renal disease as well as for the monitoring of renal dialysis. Creatinine concentrations in urine can be used with serum creatinine to calculate a clearance rate known as a measure of glomerular filtration Rate (GFR).

Reference intervals 80-120 m/L minInterferences

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Assay Creatine KinaseSynonyms CKSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications The determination of CK activity is

utilised in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy. Following injury to the myocardium, such as occurs with acute myocardial infarction, CK is released from the damaged myocardial cells. Levels may be normal in the first 4-6 hours following infarction. Peak levels seen at 24-48 hours post infarct.

Reference intervals <15 years: 25-200 u/L,Female > 15: 25-200 u/L,Male >15: 40-350 u/L

Interferences

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Assay CryoglobulinsSynonyms CRYOSample type SST (Gold top)Test instructions This test requires specific specimen

handling procedures, with the samples maintained above body temperature

Referral laboratory Protein labSt. George’s

Turnaround time N/ATest indications Used in the investigation of

cryoglobulinaemiaReference intervals N/AInterferences

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Assay CSF GlucoseSynonymsSample type CSF sample, universal containerTest instructionsReferral laboratory N/ATurnaround timeTest indications Used in the investigation of meningitis.

CSF Biochemistry investigations include CSF protein and CSF glucose.

Reference intervals 2-4.5 mmol/LInterferences

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Assay CSF LactateSynonymsSample type CSF Sample, universal containerTest instructionsReferral laboratory N/ATurnaround timeTest indications Used in the investigation of meningitis.

CSF Biochemistry investigations include CSF protein and CSF glucose.

Reference intervals <8 years: 1.1-1.8 mmol/L>8 years: 1.2-2.1 mmol/L

Interferences

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Assay CSF Oligoclonal bandsSynonymsSample type CSF Sample and SST (Gold top)Test instructions CSF Oligoclonal bands must have

accompanying serum sample (collected within 24 hours of the CSF collection)

Referral laboratory Reference Biochemistry Department at King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 15 DaysTest indications Used in the investigation of multiple

sclerosisReference intervals N/AInterferences

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Assay CSF ProteinSynonymsSample type CSF sample, universal containerTest instructions N/AReferral laboratory N/ATurnaround timeTest indications Used in the investigation of meningitis.

CSF Biochemistry investigations include CSF protein and CSF glucose.

Reference intervals 0.1-0.5 g/LInterferences

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Assay CSF XanthrochromiaSynonymsSample type CSF sample, universal containerTest instructionsReferral laboratory N/ATurnaround timeTest indications Used in the investigation of

subarrachanoid haemorrhage (SAH). CSF Xanthrochromia investigations should only be undertaken in patients suspected of suffering an SAH, where CT scan findings for a cerebral bleed is negative or equivocal. It may remain positive for 2 weeks aftet the event. The LP should only be performed >12 hours after the onset of presenting symptoms .

Reference intervals N/AInterferences

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Assay CyclosporinSynonyms CycloSample type EDTA (Purple top)Test instructionsReferral laboratory Clinical Biochemistry - Blood Sciences at

King's College Hospital020 3299 4126King's College HospitalBessemer WingDenmark HillLondon SE5 9RS

Turnaround time 7 daysTest indications Used in the therapeutic drug monitoring

of cyclosporin treatmentReference intervals No therapeutic range can be quoted due

to marked pharmokinetic and drug regime differences between patients

Interferences

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Assay Dehydroepiandrosterone SulphateSynonyms DHEAS, DHASSample type SST (Gold top)Test instructionsReferral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 14 DaysTest indications DHEAS is measured to evaluate adrenal

function and certain adrenal tumours, and to investigate the cause of virilisation in girls or early puberty in boys.

Reference intervalsInterferences

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Assay DigoxinSynonyms DigSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Digoxin is a digitalis glycoside that exerts

a positive inotropic effect that subsequently increases the contractile response of the myocardial fibers in patients experiencing congestive heart failure. Cardiac glycosides also can produce several electrophysiologic effects that produce negative chronotropic effects on the human heart. These effects tend to slow down and regulate a rapid, irregular beat like that found in patients experiencing cardiac arrhythmias. Estimation of digoxin levels may be useful when establishing a dosage for new patients, monitoring

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compliance or assessing for toxicity.Reference intervals 0.5-1 ug/LInterferences

Assay Direct bilirubinSynonyms DBIL, Conjugated bilirubinSample type SST (Gold top)Test instructions N/AReferral laboratory N/ATurnaround timeTest indications Diseases or conditions which, through

hemolytic processes, produce bilirubin faster than the liver can metabolize it, cause the levels of unconjugated (indirect) bilirubin to increase in the circulation. Liver immaturity and several other diseases in which the bilirubin conjugation mechanism is impaired cause similar elevations of circulating unconjugated bilirubin. Bile duct obstruction or damage to hepatocellular structure causes increases in the levels of both conjugated (direct) and

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unconjugated (indirect) bilirubin in the circulation

Reference intervals <1 year: 1-5 umol/L1-9 years: 1-3 umol/L9-13 years: 1-5 umol/L13-19 years: 1-7 umol/L>19 years: 1-4 umol/L

Interferences

Assay Drug of abuseSynonyms DOASample type Universal containerTest instructions Random sampleReferral laboratory Toxicology Department at King's Hospital

020 3299 [email protected]'s College HospitalBessemer Wing - 3rd FloorDenmark HillLondon SE5 9RS

Turnaround time 1 weekTest indications Used in the investigation of DOA toxicity.

Please note this test is for clinical purposes only

Reference intervals N/A

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Interferences

Assay D-DimerSynonyms DVT, PESample type Citrate (Blue top)Test instructions N/AReferral laboratory N/ATurnaround time 3 hoursTest indications Investigation of Deep Vein

Thrombosis/Pulmonary Embolism, and Disseminated Intravascular Coagulation (DIC). A negative D-dimer assay is useful in the exclusion of DVT in low risk patients and may be used to aid diagnosis of PE in some cases. It must be used in conjunction with a clinical scoring system. A positive result has no significance. All D-dimer requests for

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patients with a possible PE must be accompanied by a copy of the clinical score sheet.

Reference intervals <230 ng/mLInterferences

Assay ElastaseSynonyms FELSSample type Faecal sample universal containerTest instructionsReferral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 2 weeksTest indications Elastase is a pancreatic enzyme that is

not cleaved during its passage through

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the bowel. In the presence of exocrine pancreatic insufficiency or disorders of exocrine pancreatic function, the elastase secretion is reduced; thus resulting in a decrease of the faecal concentration of this enzyme.

Reference intervals Normal: 200 - >500 µg E1/g faeces

Moderate to mild exocrine pancreatic insufficiency: 100 – 200 µg E1/g faeces

Severe exocrine pancreatic insufficiency: <100 µg E1/g faeces

Interferences

Assay ErythropoetinSynonyms EPOSample type SST (Gold top)Test instructionsReferral laboratory Reference Biochemistry Department at

King's College Hospital020 3299 4107King's College HospitalDenmark HillLondon SE5 9RS

Turnaround time 1 week

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Test indications Used in the monitoring of anaemia secondary to renal disease

Reference intervals 5 to 25 U/LInterferences

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