ADmark® Alzheimer's Evaluation, CSF

ALZ

92433

ALZHEIMER‚S EVALUATION

Beta-Amyloid (1-42), CSF
tTau, CSF
pTau181, CSF
tTau/Abeta42 Ratio
pTau181/Abeta42 Ratio

2.5 mL CSF collected in a 2.5 mL Sarstedt low-bind false bottom tube (63.614.625, Quest Diagnostics supply part # ST100)

1 mL Sarstedt low-bind false bottom tube • 0.7 mL Sarstedt low protein-binding tube

1.5 mL CSF collected in a 1.5 mL Sarstedt low protein-binding tube (72.703.600)

Perform lumbar puncture (LP) using gravity drip collection method. Avoid the use of syringes or tubings. Perform lumbar puncture (LP) before noon. Do not use the first 2 mL of CSF for AD Biomarker measurement. Subsequently, collect 2.5 mL of CSF directly into 2.5 mL Sarstedt (63.614.625) tube, or 1.5 mL of CSF directly into 1.5 mL Sarstedt (72.703.600) tube, for AD biomarker measurements. Filling tube at least 50% full is recommended. Each sample should be visually inspected for hemolysis. Do not use CSF samples which appear reddish. Instead, collect additional clear (non-hemolytic) CSF in a new Sarstedt tube.

Do not process the CSF sample before transport to the measuring site (i.e., no mixing/inverting, no tube transfers, no aliquoting, and normally no centrifugation) until measurement. It is strongly recommended that the sample be kept at 2 to 8° C or -15 to -25° C during transport and storage up to the time of measurement.

Only the specimen listed is acceptable for use with this assay. Standard CSF polystyrene collection tubes are NOT acceptable as exposing CSF to polystyrene tubes may decrease Abeta42 concentrations.

Refrigerated (cold packs)

Room temperature: 5 days
Refrigerated: 14 days
Frozen: 56 days

Gross hemolysis • Polystyrene and polypropylene tubes other than Sarstedt (63.614.625) 2.5 mL and (72.703.600) 1.5 mL

Set up: Mon, Wed, Fri, Sat; Report available: 3-5 days

Elecsys Beta Amyloid (1 42) CSF II, Phospho-Tau (181P) CSF and Elecsys Total Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the Beta Amyloid (1 42) (Abeta42), PTau (181P) and Total Tau (tTau) protein concentration in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a tTau/Abeta42 and pTau-181/Abeta42 ratios and values. A negative result, defined as tTau/Abeta42 and Phospho-Tau (181P) ratio values below cutoff or an Abeta42 value above the measuring range, are consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive result, defined as tTau/Abeta42 and pTau181/Abeta42 ratio value above cutoff, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 and pTau181/Abeta42 ratio results are used as an adjunct to other clinical diagnostic evaluations.