CRYOcheck Lupus Anti-Coagulant Testing

CRYOcheck™ Lupus Anti-Coagulant Testing

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2 3 freephone order 0800 387732 email order [email protected] pricing and online ordering at www.alphalabs.co.uk Developed by Supplied by

Associated Products from

Screening: LA Check

Mixing: Pooled Normal

Plasma

Confirmatory:- LA Sure

(in conjunction with LA Check)

- Platelet Lysate

Integrated Screen & Confirm: Hex LA

Quality Control: - Lupus Positive

Control- Lupus Negative

Control - Weak Lupus Positive

Control

Lupus Anticoagulant Testing Pathway

Generalised testing on blood samples from asymptomatic patients

are discouraged to avoid false positive results.

It is preferable for samples to be obtained prior to, or in the absence

of, anticoagulant therapy as this may interfere with the assay.

Screening Test:

■ Two tests based on different principles must be performed

■ dRVVT should be the first test considered

■ The second test should be a sensitive aPTT with a low

phospholipid concentration and silica as an activator

Mixing Study:

■ To rule out inhibitors or factor deficiencies

■ Pooled normal plasma for mixing studies can be prepared in house, or

a commercially available lyophilised or frozen pooled normal plasma may be

used■ A 1:1 proportion of patient: pooled

normal plasma should be used

Confirmatory Test:

■ Must be performed by increasing the concentration of phospholipids of the

screening tests■ Bilayer or hexagonal (II) phase

phospholipids should be used to increase the concentration

If both tests are negative = Negative for LA

If one of the two tests are positive (e.g. a prolonged

clotting time), a mixing study should be performed.

If the result of the mixing study is prolonged, a

confirmatory test to show phospholipid dependence is

performed.

If the addition of pooled normal plasma corrects the aPTT

= Negative for LA

If the clot time is corrected (e.g. shortened), this may

indicate the presence of lupus anticoagulant.

If a patient tests positive for lupus anticoagulant, testing

must be repeated more than 12 weeks after the initial testing.

Patient presents with:

■ Unexplained prolonged aPTTand/or

■ Arterial or venous thrombosisand/or

■Unexplained recurrent foetal loss


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CRYOcheck™ LA Check is a dilute Russell’s Viper Venom Time (dRVVT) reagent intended to screen for the presence of lupus anticoagulant (LA) in citrated human plasma.

The reagent contains Russell’s viper venom, phospholipids, and anti-heparin agents.

CRYOcheck LA Check can be used in conjunction with CRYOcheck LA Sure to confirm the presence of LAs.

Both CRYOcheck LA Check and CRYOcheck LA Sure can be used with CRYOcheck Lupus Positive Control, CRYOcheck Weak Lupus Positive Control, CRYOcheckLupus Negative Control, CRYOcheck Pooled Normal Plasma and CRYOcheck Platelet Lysate.

Benefits

■ No reconstitution errors■ Easily adapted to manual, semi-automated, and

automated instrumentation (protocols for most instrumentation available upon request)

■ Unused reagent may be refrozen once■ Packaging and vials are compact and colour-coded

for easy storage and location in freezers ■ Convenient frozen format – ready to use within

minutes of thawing■ 48-hour stability once thawed when maintained at

2 to 8 C ■ Expiry dating of 3 years from the date of

manufacture when stored at -40 to -80 C■ Screening and confirmatory reagents are sold

separately to eliminate excess stock of either product in your lab

CRYOcheck™ Pooled Normal Plasma is intended for use as a frozen alternative to in-house collected normal plasma pools, and provides users with enhanced convenience and increased confidence in testing results.

CRYOcheck Pooled Normal Plasma is comprised of platelet-poor plasma from 20 or more carefully screened male and female donors between 18 and 66 years of age. The plasma is buffered and frozen, resulting in a top quality, versatile product that truly represents “normal”.

Benefits

■ Platelet-poor (< 10,000 platelets/µL) ■ Each lot number is verified to be normal (factor

assay value sheet available upon request) ■ Screened negative for lupus anticoagulants ■ Buffered to enhance pH stability ■ 24-hour stability once thawed when maintained at

2 to 8 °C ■ Carefully screened for plasma clarity ■ Expiry dating of 2 years from the date of

manufacture when stored at -40 to -80 °C ■ May also be used as a normal control for

prothrombin time (PT) and activated partial thromboplastin time (APTT)

CRYOcheck™ LA Sure is a dilute Russell’s Viper Venom Time (dRVVT) reagent intended to confirm the presence of lupus anticoagulant (LA) in citrated human plasma.

CRYOcheck LA Sure has a high phospholipid concentration that neutralizes LA and therefore demonstrates the correction needed to report positive LA results with confidence.

Benefits

■ No reconstitution errors ■ Easily adapted to manual, semi-automated, and

automated instrumentation (protocols for most instrumentation available upon request)

■ Unused reagent may be refrozen once ■ Packaging and vials are compact and colour-coded

for easy storage and location in freezers ■ Convenient frozen format – ready to use within

minutes of thawing■ 48-hour stability once thawed when maintained at

2 to 8 ºC ■ Expiry dating of 3 years from the date of

manufacture when stored at -40 to -80 °C■ Screening and confirmatory reagents are sold

separately to eliminate excess stock of either product in your lab

CRYOcheck LA Check and CRYOcheck LA Sure can be used in conjunction with CRYOcheck Lupus Positive Con-trol, CRYOcheck Weak Lupus Positive Control, CRYOcheckLupus Negative Control, CRYOcheck Pooled Normal Plasma and CRYOcheck Platelet Lysate.

CRYOcheck™ Platelet Lysate is a source of phospholipids intended for use in the platelet neutralization procedure (PNP) used to detect lupus anticoagulants (LA).

Platelets are thoroughly washed to remove other cellular and protein contaminants, and held at a concentration of 250,000 to 300,000 platelets/µL, then lysed by a freeze/thaw cycle.

Benefits

■ Frozen format eliminates reconstitution errors■ Replaces in-house collection and washing of

platelets for the PNP■ 8-hour stability once thawed if refrigerated at 2 °C

to 8 °C in the original capped vial


Screen Products Confirm Products

Mix Products

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CRYOcheck Hex LA is a qualitative test kit to aid in the detection of lupus anticoagulant (LA) by the application of hexagonal phase phospholipids.

CRYOcheck Hex LA is an integrated (screen and confirm) silica-based APTT assay. The presence of LA in a sample is confirmed by the correction of APTT clot time upon addition of a reaction mixture containing hexagonal phase phospholipid. By comparing clot times of patient plasma both in the presence and absence of hexagonal phase phospholipid, the presence of LA can be confirmed. CRYOcheck Hex LA’s LA Start and LA Correct reagents contain pooled normal plasma and a heparin neutralizer.

This ensures that prolongation of clot times due to factor deficiencies are corrected and that the assay is unaffected by heparin levels up to 2 IU/mL. Hex LA has been designed to work on many common automated coagulation analysers, giving you a simple, fast method for LA detection as part of your LA test panel. All of this adds up to a dramatic time savings by allowing you to load your reagents faster and report LA results with confidence.

Benefits■ Convenient frozen format – ready to use within

minutes, no reconstitution errors■ Intended for use on automated coagulation

analysers■ Simple format: minimal vials means less preparation

time and faster results ■ Unaffected by unfractionated heparin (UFH) and

low molecular weight heparin (LMWH) up to 2 IU/mL

■ Dabigatran, rivaroxaban, and fondaparinux do not interfere with the interpretation of CRYOcheck Hex LA results nor does C-reactive protein

■ 8-hour stability on board analyser

KIT COMPONENTS: LA Start: Pooled normal plasma LA Correct: Pooled normal plasma with inverted hexagonal phase phospholipids LA APTT: LA sensitive APTT reagent

CRYOcheck lupus controls are intended for use as controls in lupus anticoagulant (LA) assays. The controls provide users with enhanced convenience and increased confidence in their testing systems.

The plasmas are buffered and frozen, resulting in top quality products that eliminate reconstitution errors and the inconvenience of in-house plasma collection.

Packaging and vials are compact and colour-coded for easy storage and location in freezers. All can be used in conjunction with our CRYOcheck LA Check™, CRYOcheckLA Sure™ and CRYOcheck Hex LA™.

Lupus Positive Control and Weak Lupus Positive Control are both comprised of platelet-poor plasmas from donors confirmed to have circulating LA. Lupus Positive Control is a distinctly positive LA control, while Weak Lupus Positive Control is a weak positive LA control that challenges a reagent’s

sensitivity to LA. Users can be confident that weak LA positive patient samples are accurately detected.

Lupus Negative Control is comprised of platelet-poor plasma from donors screened negative for LA.

■ 8-hour stability once thawed when maintained at 2 to 8 °C

■ Expiry dating of 2 years from date of manufacture when stored at -40 to -80 °C

Quality Control Products

Product Code Description Pack Size

CCLP-05 CRYOcheck™ Lupus Positive Control 25 x 0.5mlCCLP-10 CRYOcheck™ Lupus Positive Control 25 x 1.0mlCCWLP-05 CRYOcheck™ Lupus Weak Positive Control 25 x 0.5mlCCWLP-10 CRYOcheck™ Lupus Weak Positive Control 25 x 1.0mlCCLN-05 CRYOcheck™ Lupus Negative Control 25 x 0.5mlCCLN-10 CRYOcheck™ Lupus Negative Control 25 x 1.0ml


Quality Control Products

Integrated Screen and Confirm Products

Screen Products


CHK25-10 CRYOcheck™ LA Check screening test 25 x 1ml

Mix Products


CCN-10 CRYOcheck™ Pooled Normal Plasma 80 x 1.0mlCCN-15 CRYOcheck™ Pooled Normal Plasma 80 x 1.5mlCCN-40 CRYOcheck™ Pooled Normal Plasma 81 x 4.0ml

Confirm Products


SUR25-10 CRYOcheck™ LA Sure DRVVT reagent 25 x 1mlPNP-10 CRYOcheck™ Platelet Lysate 25 x 1ml

Integrated Products


HEXLA CRYOcheck™ Hex LA qualitative test kit 2 x 1.5 ml

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Uncover Savings in Your Laboratory

Platform independentThe CRYOcheck range of frozen plasmas are platform independent and can be used on any analyser, in combination with any reagents - easy to introduce into your laboratory!

Sensitivity to system changesPrecision BioLogic’s range of controls are more representative of patient samples, making them sensitive to system changes, which can help to identify errors earlier, saving your lab time and money.

Thaw and goWith Precision BioLogic’s frozen format, simply thaw for a few minutes and reagents are ready for use! Eliminating the reconstitution process reduces the chance of errors, meaning fewer re-runs and less wasted product, saving your laboratory money. No time wasted waiting for the product to acclimatise.

Unmatched customer careWhen you call Alpha Laboratories, you are put in touch with the person who sees your order through from start to finish. We treat every order with care and attention to ensure that your order arrives on time and ready to use.

Vial-to-vial consistencyThese frozen plasmas do not need to be reconstituted before use. When reconstituting lyophilised products, even a slight deviation in process from one vial to the next can increase imprecision and adversely impact results.

Faster results + improved accuracy = better patient care

Fresh frozen plasmas are quick and easy to prepare,

more representative of patient samples, and

without reconstitution errors, meaning faster

more accurate results for your patients.

Reduced Labour CostsOur fresh frozen plasmas

are quick and easy to prepare. Just thaw in a few minutes and they are ready for use. This

helps save you time and money on labour, whilst improving efficiency by

freeing up technologists to perform other tasks.

Convenient sizesProducts are available in different size formats to

best meet your testing requirements. Use what is required, no more, no less and avoid having to throw product away, helping you

to save money.

Extended shelf lifeWhen stored at the recommended

temperature, these products are stable for at least two years from the date of

manufacture, and in many cases, up to three years. This means less expired product to throw away and fewer lot

changeovers, saving you time and money.

Freezer efficientCompact packaging takes up minimal

space in your freezer. The helpful colour coded design makes it easier to find

the right product.

The Value of Precision Precision BioLogic’s CRYOcheck™ range of fresh frozen plasmas can help your laboratory to save time and money,

whilst offering faster more accurate results for your patients.

Alpha Laboratories Limited40 Parham DriveEastleigh, HampshireSO50 4NU United Kingdom

Tel: 023 8048 3000Fax: 023 8064 3701Email: [email protected]: www.alphalabs.co.uk

JBN338 06.21

Documents

CRYOcheck Lupus Anti-Coagulant Testing