In this section, we will tell you about our newest products – novel assays that will not only enhance our current product portfolio, but also allow us to offer you even better support.

  • ARK™ Methotrexate Assay

    Tumor CellThe ARK™ Methotrexate Assay is a highly specific homogeneous enzyme immunoassay for the accurate quantitative determination of methotrexate in human serum or plasma. The assay provides reliable results for the monitoring of methotrexate levels even at concentrations as low as 0.05 µmol/L. More importantly, the assay has a very low cross-reactivity to 7-Hydroxymethotrexate, the major metabolite of Methotrexate.

    The liquid reagents, calibrators and controls are ready to use directly out of the fridge. Pack sizes have been designed to match the typical workloads in a routine lab. ARK™ Methotrexate reagents, calibrators and controls are CE marked and suitable for all major clinical chemistry analyzers. Applications are available for a number of instruments, including Abbott ARCHITECT®, Beckman Coulter AU Series, Roche Cobas® and Siemens ADVIA®.

    Assay Characteristics

    • Very low cross-reactivity to 7-Hydroxymethotrexate (≤ 0.07%)
    • Well suited for the detection of MTx in the low ranges, with a limit of detection at 0.02 µmol/L and a limit of quantification at 0.04 µmol/L.
    • Dilution protocols are available to extend the concentration range up to 1 000 µmol/L
    • Convenient, liquid-stable, ready-to-use format
    • Applications are available for all major automated clinical chemistry analysers
    • Excellent calibration range
    • The calibration curve is stable from 3 days to up to 6 weeks, depending on instrument type and work load
    • Non-hazardous preservatives do not contain sodium azide
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  • ARK™ Oxcarbazepine Metabolite Assay

    oxcarbazepine

    Specialty Diagnostix and ARK Diagnostics introduce the first homogeneous immunoassay for the Therapeutic Drug Monitoring of the Oxcarbazepine Metabolite 10,11-dihydro-10-hydroxy-5H-dibenz[b,f]azepine-5-carboxamide (or 10-Monohydroxy derivative [MHD] of Oxcarbazepine) in human serum. The ARK™ Oxcarbazepine Metabolite Assay provides a fast, sensitive and convenient alternative to the more time-consuming chromatographic methods.

    Oxcarbazepine is used in the treatment of epilepsy, anxiety and mood disorders as well as benign motor tics. In addition, it seems to be effective in patients with bipolar disorders. Both the chemical structure and therapeutic activity of Oxcarbazepine are similar to Carbamazepine, but with a considerably reduced potential for negative side effects.

    Oxcarbazepine is a next generation anti-convulsant and mood-stabilizing agent and, similar to Eslicarbazepine acetate, a so called pro-drug that is metabolized to the active, clinically relevant metabolite MHD, which has an (S)-(+)- and an (R)-(-)-enantiomer. However, only the pharmacokinetics of the racemate are actually reported.

    Serum concentrations of 3 to 35 µg/mL of the active Oxcarbazepine Metabolite are associated with a clinically effective control of partial seizures. Adverse effects may occur at concentrations exceeding 35 µg/mL. Therapeutic Drug Monitoring is justified when changes are expected that might alter the clearance of the Oxcarbazepine Metabolite. These may include pregnancy, the concomitant use of liver enzyme inducing medication or renal insufficiency.

     

    Assay Characteristics

    • A convenient and simple method for the monitoring of Oxcarbazepine Metabolite
    • Excellent precision and recovery
    • Highly specific and sensitive assay for the detection of Oxcarbazepine Metabolite even in trough level concentrations
    • No cross-reactivity with structurally unrelated AEDs
    • No time-consuming sample preparation and extraction
    • Liquid, stable, ready-to-use reagent, calibrators and controls
    • Application protocols for all major clinical chemistry analyzers
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  • Pregabalin

    pregabalin

    Originally designed as a more potent successor to Gabapentin, Pregabalin is an anticonvulsant serving as a first-line antiepileptic agent. It is also particularly effective in the treatment of neuropathic pain and generalized anxiety syndromes. In Europe, Pregabalin is the only medication approved for the treatment of central and peripheral neuropathic disorders.

    Although it is officially considered to have only a low potential for abuse, a growing number of publications report actual misuse of pregabalin, especially in patients with a history of substance abuse. In addition, patients treated with pregabalin seem to develop a tolerance with regular use that might easily slide into addiction. Withdrawal effects may be severe.

    The new Pregabalin Assay from ARK Diagnostics, Inc. and Specialty Diagnostix is the first homogeneous enzyme immunoassay available for Pregabalin. It is a fast, sensitive and convenient alternative to the more time-consuming chromatographic methods to establish abuse or misuse of Pregabalin and may be easily integrated into existing drugs of abuse screening procedures.

    Assay Characteristics

    • Convenient and simple screening method for Pregabalin, especially in the forensic context
    • Highly specific and sensitive assay for the detection of Pregabalin even in low concentrations
    • No time-consuming sample preparation and extraction
    • Liquid, stable, ready-to-use reagents, calibrators and controls
    • Application protocols for all major clinical chemistry analyzers
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  • Fentanyl

    fentanyl

    Fentanyl is a potent synthetic opioid analgesic which has been introduced as a widespread palliative, especially in form of transdermal patches and other quick-acting prescription forms in chronic pain management and for cancer patients. For the past several years Fentanyl has also been used as a recreational drug. Apparently, its effects are similar to that of heroin, but have stronger sedative results. Since Fentanyl is a very short-acting drug, users become addicted quite rapidly.

    The SEFRIA™ Fentanyl Assay will be the first of a new range of cutting-edge enzyme immunoassays, utilizing both synthetic and recombinant enzyme fragments of beta-galactosidase for superb sensitivity and vastly improved analysis.

    Due to its extremely low cut-off, this assay is especially suited for the monitoring of transdermal patches and oral transmucosal Fentanyl citrate lollipops. The SEFRIA™ Fentanyl Assay is a strong screening tool to monitor compliance on the one hand, and for the detection of Fentanyl abuse on the other.

     

    Assay Characteristics

    • Cut-off as low as 1 ng/mL leads to fewer false-negative results
    • Excellent separation between controls and calibrators
    • No cross-reactivity with norfentanyl
    • Liquid-stable, ready-to-use reagents, calibrators, and controls
    • Application protocols for all major clinical chemistry analyzers
    • Packaging tailored to your laboratory’s unique needs
    • Use of synthetic material to enhance stability of calibrators and controls, and to decrease risk of contamination
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  • Synthetic Cannabinoids = Spice

    spice

    Specialty Diagnostix offers a two-pronged approach to the analysis of synthetic cannabinoids to counter the new Spice compounds rapidly emerging on the market.

    The Synthetic Cannabinoids-1 assay has been the first commercially available homogeneous enzyme immunoassay for the detection of synthetic cannabinoids and their metabolites in urine.

    With the new Synthetic Cannabinoids-2 assay, we provide the means to challenge the next generation of Spice and other herbal blends, such as UR-144 or XLR-11. This homogeneous enzyme immunoassay effectively complements the already available Synthetic Cannabinoids-1 assay.

    The combination of these two assays provides a potent screening tool for a wide range of synthetic cannabinoids. Neither of the two kits requires any sample preparation. Both offer a high throughput and excellent sensitivity, specificity and efficiency, and present a broad cross-reactivity profile. Together, they enhance their individual screening capacities for optimal results.

    Assay Characteristics – Synthetic Cannabinoids-1

    • Qualitative determination of synthetic cannabinoids in urine
    • Antibody identifies naphthoylindole metabolites
    • Detection of the majority of synthetic cannabinoid compounds, e.g. JWH-018, JWH-073, AM-2201 and their free and conjugated metabolites
    • Liquid, ready-to-use reagents, calibrators and controls – no need for reconstitution
    • Application protocols for all major clinical chemistry analysers
    • Packaging tailored to match most routine laboratory workloads
     

    Assay Characteristics – Synthetic Cannabinoids-2

    • Qualitative determination of the newest generation of synthetic cannabinoids in urine
    • Highly sensitive detection of UR-144 and XLR-11, including their derivatives
    • Comprehensive, rapid and cost-effective screening solution
    • Liquid, ready-to-use reagents, calibrators and controls – no reconstitution required
    • Application protocols for all major clinical chemistry analysers
    • Packaging tailored to match most routine laboratory workloads
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  • Voriconazole

    vori

    The ARK™ Voriconazole II Assay is a highly specific homogeneous enzyme immunoassay for the therapeutic drug monitoring of Voriconazole in human serum or plasma. The assay provides excellent precision at very low concentrations, an essential quality in the long-term monitoring of patients.

    Voriconazole is a broad-spectrum, second generation triazole antifungal agent. It is currently considered to be the drug of choice for the treatment of invasive aspergillosis, candidiasis and other serious mycoses, a major cause of life-threatening infections in immune-compromised patients.

    The drug is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine. Due to its high inter- and intra-individual pharmacokinetics, it is crucial to monitor serum levels to ensure optimal patient treatment. In addition, voriconazole pharmacokinetics are non-linear, which is why dose increases may lead to disproportionately higher drug exposure. There are also a substantial number of drug-drug interactions that may either reduce or increase the effective exposure of voriconazole. As a consequence, it is extremely difficult to produce predictable trough concentrations.

    Because of its ability to measure trough voriconazole levels with high accuracy and fast turn-around time, the assay is a useful method for Therapeutic Drug Monitoring of voriconazole, without any cross-reactivity to the primary metabolite Voriconazole-N-Oxide.

    Assay Characteristics

    • Excellent precision even at very low concentrations
    • Trough level measurement with high accuracy
    • No cross-reactivity to the major metabolite Voriconazole-N-oxide
    • Liquid, stable, ready-to-use reagents, calibrators and controls
    • Application protocols for all major clinical chemistry analyzers
    Learn more...
  • Ketamine Urine HEIA

    Ketamine

    The Ketamine Urine HEIA is the newest addition to the comprehensive Specialty Diagnostix and Immunalysis Drugs of Abuse portfolio. Ketamine is used as an anesthetic and analgesic in emergency medicine, especially in situations where immediate pain relief is important. Because of its unwanted severe psychedelic episodes in adults, it is mostly used for children or individuals undergoing minor surgery. In addition, Ketamine is employed in veterinary medicine.

    In many countries, Ketamine has become popular as a recreational drug. However, the side effects may include horror trips or the K-Hole, a slang term to describe the subjective state of dissociation from the body caused by ketamine. Ketamine is known under various street names such as K, Special K, Vitamin K, Kate, Keta, Ketamine C. Due to its purported ability to cause confusion and amnesiac effects, ketamine is sometimes used as a date rape drug.

    This highly sensitive enzyme immunoassay provides a reliable and rapid method for the specific detection of Ketamine in human urine samples.

    Assay Characteristics

    • Liquid, ready-to-use reagents, calibrators, and controls – no reconstitution required
    • Application protocols for all major clinical chemistry analyzers
    • Packaging tailored to your laboratory's unique needs
    • Use of synthetic material to enhance stability of calibrators and controls, and to decrease risk of contamination
    Learn more...
  • Immunalysis 6-Acetylmorphine (6-AM) Urine HEIA

    Pods of the poppy Papaver somniferum with seedsThe new 6-Actylmorphine (6-AM) Urine HEIA offers a highly specific and extremely sensitive method for the determination of recent heroin abuse.

    Based on the new recombinant antigen-binding fragment (rFAB) technology, this homogeneous enzyme immunoassay is an excellent tool to distinguish between samples that are positive due to heroin consumption and samples that are positive due to morphine intake, prescription medication or poppy seed ingestion.

    The reduction of false positive screenings helps to minimize costs for confirmation testing provides more confidence in current screening techniques.

     

    Assay Characteristics

    • rFAB technology for enhanced performance, superior specificity and targeted selectivity
    • Virtually no cross-reactivity to morphine and its metabolites (XR < 0,005%)
    • No significant cross-reactivity to other relevant opiates (i.e. codeine, dihydrocodeine & morphine glucuronides)
    • Liquid, ready-to-use reagents, calibrators, and controls – no reconstitution
    • Application protocols for all major clinical chemistry analysers
    • Packaging tailored to your laboratory’s unique needs
    • Use of synthetic material to enhance stability of calibrators and controls, and to decrease risk of contamination
    Learn more...
  • Buprenorphine

    Bup02When compliance testing is the main goal of an application, getting an accurate screening result for Buprenorphine is crucial.

    Highly specific to free Buprenorphine and Norbuprenorphine, this innovative immunoassay for the qualitative and semi-quantitative detection of buprenorphine shows virtually no cross-reactivity to commonly prescribed opiates and opioids.

    The antibody employed binds specifically and almost equally to free buprenorphine and its main metabolite norbuprenorphine.

    The Immunalysis HEIA™ Buprenorphine assay shows an excellent performance with respect to precision (CVs < 6 %), linearity (R = 0,9995) and sensitivity (sensitivity limit = 0.32 ng/mL) on the Beckman Coulter AU400 analyser system.

    The assay provides an adequately sensitive and specific screening for buprenorphine in urine samples at a cut-off concentration of 5 ng/mL.

    Assay Characteristics

    • Antibody specific to Buprenorphine and Norbuprenorphine
    • Extremely low cross-reactivity to morphine and other opioids, e.g. codeine, dihydrocodeine, tramadol, etc.
    • Liquid, ready-to-use reagents, calibrators, and controls – no reconstitution necessary
    • Application protocols for all major clinical chemistry analysers
    • Packaging matched to most common routine laboratory workloads
    • Use of synthetic material to enhance stability of calibrators and controls to decrease risk of contamination
    Learn more...
  • EDDP Specific Urine HEIA

    Bup02Specialty Diagnostix presents a new specific homogeneous enzyme immunoassay for the detection of the Methadone Metabolite EDDP in urine. This EDDP specific urine assay is a sensitive and reliable method to monitor patient compliance in opiate withdrawal programs.

    Methadone is a synthetic compound that was originally developed in World War II as an alternative to morphine, which was in short supply. Its pharmacological properties are similar to heroin and morphine, but with stable dosing it causes neither euphoria nor intoxication. Experience has proved that methadone maintenance is quite effective in the treatment of opioid addiction.

    Monitoring for methadone compliance by means of methadone immunoassays has some disadvantages. The most important of those is probably the fact that methadone renal clearance is dependent on urinary pH. An alkaline urine pH > 7 may reduce renal clearance of unmetabolized methadone considerably. Thus, a urine specimen may not contain enough methadone to yield a positive drug screen. Since a negative test result implies non-compliance, a patient enrolled in a methadone substitution program would be in serious trouble. The renal clearance of EDDP (2-Ethylidin-1,5-Dimethyl-3,3-Diphenyl-Pyrolidine), the primary Methadone Metabolite, on the other hand, remains unaffected by an alkaline urine. Thus, testing for EDDP provides positive evidence of the patient’s compliance.

    If a patient tries to fake compliance by spiking his own urine with a small amount of methadone to cause a positive result for a Methadone screening, testing for EDDP is proof positive that the patient has not, in fact, ingested the drug. Moreover, testing for EDDP will also detect those that actually take their methadone dose but try to hide co-consumption of other drugs by presenting someone else’s urine sample spiked with a small amount of methadone.

    EDDP immunoassay detection may be used to either complement or replace the screening for methadone. The new EDDP Specific Urine Assay will not only make compliance testing easier, it will also help to rule out possible tampering with urine samples.

    Assay Characteristics

    • Highly sensitive and specific method to detect EDDP in human urine samples
    • Three distinct cut-offs – 100 ng/mL, 300 ng/mL & 1000 ng/mL for qualitative and 100 ng/mL & 300 ng/mL for
         semi-quantitative analysis
    • Liquid, stable, ready-to-use reagents, calibrators and controls – no reconstitution required
    • Application protocols available for all major clinical chemistry analyzers
    • Packaging tailored to your laboratory’s specific needs
    Learn more...
  • Synthetic Cannabinoids-3 Assay

    Spice 3Specialty Diagnostix and Immunalysis now introduce a third homogeneous enzyme immunoassay for the detection of synthetic cannabinoids in urine. While Synthetic Cannabinoid Assays 1 and 2 targeted the first and second generation compounds and their respective metabolites, the new Synthetic Cannabinoid-3 Assay is intended for the analysis of AB-PINACA, AB-FUBINACA and their derivatives.

    AB-PINACA was originally developed by Pfizer as an analgesic medication. In rat discrimination studies, AB-PINACA was found to act as a potent agonist for the CB1 and CB2 receptors and as a full substitute for 9-THC, while being 1.5 times more potent. There have been a number of reported cases of deaths and hospitalizations connected to AB-PINACA. In Germany, the compound is listed in Anlage II and thus illegal as of November 2014. In the USA, it is a Schedule I controlled substance.

    AB-PINACA was first identified as a component of synthetic cannabinoid products in 2012. It is based on an indazole backbone, whereas most of the JWH compounds have an indolyl base. The biochemical, physiological, and toxicological properties of AB-PINACA and its derivatives have yet to be determined.

    AB-PINACA is sold under various street names, the most common being Cloud 9, Crown, and Relax. Sprayed on herbal blends or as a liquid in eyedropper bottles, it is used with vaporizing devices, such as hookahs or e-cigarettes. The most commonly reported adverse effects of herbal blends supposedly containing AB-PINACA include agitation, tachycardia, drowsiness, lethargy, vomiting and confusion. Other reported effects were difficulty in breathing, loss of motor control and/or consciousness, altered mental status, convulsions, seizures, coma and death.

    Assay Characteristics

    • Qualitative detection of AB-PINACA, AB-FUBINACA, and other currently relevant synthetic cannabinoid compounds
    • Excellent specificity and sensitivity
    • Liquid, stable, ready-to-use reagents, calibrators and controls – no reconstitution required
    • Application protocols available for all major clinical chemistry analyzers
    • Packaging tailored to your laboratory’s specific needs
    Learn more...
  • ARK™ Methylphenidate Metabolite Urine Assay

    Spice 3Methylphenidate, better known under its trade name Ritalin, belongs to the group of psychostimulants and acts as a dopamine or norepinephrine reuptake inhibitor. Ritalin is used primarily in the treatment of attention deficit hyperactivity disorders (ADHD).

    In Germany, methylphenidate is considered as a trafficable and prescribable controlled substance and thus available by BtM prescription only. According to BfArM statistics (BfArM = Federal Institute for Drugs and Medical Devices), approximately 1.716 kg methylphenidate have been sold as tablets in 2014, with increasing tendency.

     

    Methylphenidate is metabolized rapidly and almost completely to ritalinic acid. This metabolite is pharmacologically inactive, its half-life, however, is about twice as long as that of methylphenidate itself. The mechanism of action is similar to that of cocaine or amphetamine – there are good reasons why methylphenidate is also called "ersatz speed" in the drug scene. The tablets are usually taken orally, sniffed in powder form or dissolved in water and injected. The stimulating effect usually lasts about four hours. During this time, performance and concentration are augmented and the body loses its ability to recognize exhaustion or overexertion. Presumably, it is precisely this performance enhancing effect that makes methylphenidate so attractive to adults. However, there are as yet no reliable figures on the prevalence of abusive consumption.

    The new homogeneous urine enzyme immunoassay by ARK ™ Diagnostics may be used for the quantitative determination of ritalinic acid, the main metabolite of methylphenidate. As a rapid, practical alternative to far more time-consuming chromatographic methods, it is particularly suitable for the monitoring of patient compliance or the recognition of abuse. The assay may be employed on all standard clinical chemistry analyzers and thus easily integrated into a lab’s existing drug screening routine.

    Assay Characteristics

    • Highly specific detection of methylphenidate misuse in urine
    • Rapid and sensitive screening method for the monitoring of patient compliance
    • Cut-off 100 ng/mL
    • Liquid, ready-to-use reagents, calibrators and controls
    • Application protocols for all major clinical chemistry analyzers
    Learn more...