Porphyrins in Urine - HPLC

Order No.: 44000, for 100 tests
Parameters:
Coproporphyrin I, Coproporphyrin III, Heptacarboxyporphyrin, Hexacarboxyporphyrin, Pentacarboxyporphyrin, Uroporphyrin

Easy sample preparation
Stable standards and controls

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR 2017/746

Coproporphyrin I

Coproporphyrin III

Heptacarboxyporphyrin

Hexacarboxyporphyrin

Pentacarboxyporphyrin

Uroporphyrin

Clinical relevance

This assay allows the quantitative determination of uroporphyrin, heptacarboxyporphyrin, hexacarboxyporphyrin, pentacarboxyporphyrin, coproporphyrin I and coproporphyrin III in human urine samples.
The kit is intended to be used for patients in whom the urinary levels of uroporphyrin, heptacarboxyporphyrin, hexacarboxyporphyrin, pentacarboxyporphyrin, coproporphyrin I and coproporphyrin III are of clinical importance, primarily as an aid to diagnosis of suspected acute intermittent porphyria, porphyria variegata, aminolevulinic acid dehydratase deficiency porphyria, hereditary coproporphyria, porphyria cutanea tarda or congenital erythropoietic porphyria and/or for their differential diagnosis.
The kit is also intended to be used as an aid to diagnosis of lead poisoning in patients in whom the urinary levels of above listed analytes are of clinical importance after suspected lead exposure (lead itself cannot be detected with this kit).
Besides, the kit is also intended to be used as an aid to diagnosis of the Dubin-Johnson syndrome in patients in whom the urinary levels of coproporphyrin I and coproporphyrin III are of clinical interest.

 

Product advantages

• Easy sample preparation
• Stable standards and controls

 

Assay characteristics

Sample preparation consists of sample stabilisation, addition of the internal standard followed by centrifugation to separate particles that may be present in the urine. An oxidation step is not necessary as the porphyrinogens oxidise spontaneously by air into the fluorescent porphyrins. The internal standard elutes between the analytes thus avoiding analytical variation and inaccuracy as well as allowing a shortening of the chromatographic run time.

Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.

More Information
Method of Analysis HPLC
Number of Tests 100
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

Uroporphyrin: 0.48 µg/l – 1400 µg/l
Heptacarboxyporphyrin: 0.84 µg/l – 3200 µg/l
Hexacarboxyporphyrin: 1.8 µg/l – 5000 µg/l
Pentacarboxyporphyrin: 0.90 µg/l – 4600 µg/l
Coproporphyrin I: 2.2 µg/l – 5000 µg/l
Coproporphyrin III: 2.6 µg/l – 5000 µg/l

Different systems might show different performance data.

Specimen Urine
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Pipette 500 µl sample/calibrator/control into an amber reaction vial.
  • Add 50 µl Stabilisation Reagent and 50 µl Priming Solution, mix briefly (vortex) and incubate 10 min at ambient temperature.
  • Add 50 µl Internal Standard and mix briefly (vortex).
  • Centrifuge 10 min at 9000 x g.
  • Inject 25 µl supernatant into the HPLC system.
Run Time 20 min
Injection Volume 25 µl
Flow Rate 1.2 ml/min
Column Temperature +20 to +25 °C
Wavelength EX 405 nm
EM 620 nm
Gradient binary
Additional Info Any binary HPLC gradient system with fluorescence detector is suitable.
Parameters Coproporphyrin I, Coproporphyrin III, Heptacarboxyporphyrin, Hexacarboxyporphyrin, Pentacarboxyporphyrin, Uroporphyrin

44000 Porphyrins in Urine
For 100 tests

Order No. Kit components (Quantities in kit)
44001 Mobile Phase A, 1000 ml (2x)
44002 Mobile Phase B, 1000 ml (2x)
44003 Porphyrins Urine Calibration Standard (lyoph.), 5 x 2 ml (1x)
44004 Internal Standard, 5 ml (1x)
44005 Stabilisation Reagent, 5 ml (1x)
44006 Priming Solution, 5 ml (1x)
33005 Reaction Vials, amber coloured (light protection), 100 pcs. (1x)

 

Order No. Required components (not included in the kit)
44100 HPLC Column, equilibrated, with test chromatogram, 1 pc.
0145 Porphyrins Urine Control, Level I, 5 x 2 ml
0146 Porphyrins Urine Control, Level II, 5 x 2 ml
18044 Precolumn Cartridge 4/10, 1 pcs.

 

Order No. General lab equipment (non-CE/IVD products)
33005 Reaction Vials, amber coloured (light protection), 100 pcs. (1x)
15010 PEEK Prefilter Housing, 1 pc.
15009 PEEK-encased Prefilter, 5 µm, 5 pcs.
18001 Precolumn Cartridge Colder 4/10, 1 pc.
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.

Coproporphyrin I

Coproporphyrin III

Heptacarboxyporphyrin

Hexacarboxyporphyrin

Pentacarboxyporphyrin

Uroporphyrin

Clinical relevance

This assay allows the quantitative determination of uroporphyrin, heptacarboxyporphyrin, hexacarboxyporphyrin, pentacarboxyporphyrin, coproporphyrin I and coproporphyrin III in human urine samples.
The kit is intended to be used for patients in whom the urinary levels of uroporphyrin, heptacarboxyporphyrin, hexacarboxyporphyrin, pentacarboxyporphyrin, coproporphyrin I and coproporphyrin III are of clinical importance, primarily as an aid to diagnosis of suspected acute intermittent porphyria, porphyria variegata, aminolevulinic acid dehydratase deficiency porphyria, hereditary coproporphyria, porphyria cutanea tarda or congenital erythropoietic porphyria and/or for their differential diagnosis.
The kit is also intended to be used as an aid to diagnosis of lead poisoning in patients in whom the urinary levels of above listed analytes are of clinical importance after suspected lead exposure (lead itself cannot be detected with this kit).
Besides, the kit is also intended to be used as an aid to diagnosis of the Dubin-Johnson syndrome in patients in whom the urinary levels of coproporphyrin I and coproporphyrin III are of clinical interest.

 

Product advantages

• Easy sample preparation
• Stable standards and controls

 

Assay characteristics

Sample preparation consists of sample stabilisation, addition of the internal standard followed by centrifugation to separate particles that may be present in the urine. An oxidation step is not necessary as the porphyrinogens oxidise spontaneously by air into the fluorescent porphyrins. The internal standard elutes between the analytes thus avoiding analytical variation and inaccuracy as well as allowing a shortening of the chromatographic run time.

Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.

More Information
Method of Analysis HPLC
Number of Tests 100
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

Uroporphyrin: 0.48 µg/l – 1400 µg/l
Heptacarboxyporphyrin: 0.84 µg/l – 3200 µg/l
Hexacarboxyporphyrin: 1.8 µg/l – 5000 µg/l
Pentacarboxyporphyrin: 0.90 µg/l – 4600 µg/l
Coproporphyrin I: 2.2 µg/l – 5000 µg/l
Coproporphyrin III: 2.6 µg/l – 5000 µg/l

Different systems might show different performance data.

Specimen Urine
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Pipette 500 µl sample/calibrator/control into an amber reaction vial.
  • Add 50 µl Stabilisation Reagent and 50 µl Priming Solution, mix briefly (vortex) and incubate 10 min at ambient temperature.
  • Add 50 µl Internal Standard and mix briefly (vortex).
  • Centrifuge 10 min at 9000 x g.
  • Inject 25 µl supernatant into the HPLC system.
Run Time 20 min
Injection Volume 25 µl
Flow Rate 1.2 ml/min
Column Temperature +20 to +25 °C
Wavelength EX 405 nm
EM 620 nm
Gradient binary
Additional Info Any binary HPLC gradient system with fluorescence detector is suitable.
Parameters Coproporphyrin I, Coproporphyrin III, Heptacarboxyporphyrin, Hexacarboxyporphyrin, Pentacarboxyporphyrin, Uroporphyrin

44000 Porphyrins in Urine
For 100 tests

Order No. Kit components (Quantities in kit)
44001 Mobile Phase A, 1000 ml (2x)
44002 Mobile Phase B, 1000 ml (2x)
44003 Porphyrins Urine Calibration Standard (lyoph.), 5 x 2 ml (1x)
44004 Internal Standard, 5 ml (1x)
44005 Stabilisation Reagent, 5 ml (1x)
44006 Priming Solution, 5 ml (1x)
33005 Reaction Vials, amber coloured (light protection), 100 pcs. (1x)

 

Order No. Required components (not included in the kit)
44100 HPLC Column, equilibrated, with test chromatogram, 1 pc.
0145 Porphyrins Urine Control, Level I, 5 x 2 ml
0146 Porphyrins Urine Control, Level II, 5 x 2 ml
18044 Precolumn Cartridge 4/10, 1 pcs.

 

Order No. General lab equipment (non-CE/IVD products)
33005 Reaction Vials, amber coloured (light protection), 100 pcs. (1x)
15010 PEEK Prefilter Housing, 1 pc.
15009 PEEK-encased Prefilter, 5 µm, 5 pcs.
18001 Precolumn Cartridge Colder 4/10, 1 pc.
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.