DiaMed ID-Micro Typing System
AN INTRODUCTION TO “GEL TECHNOLOGY” DiaMed ID-MICRO TYPING SYSTEM Advancement in BLOOD BANKING TECHNIQUES; Blood Bank being a most essential department in the clinical diagnostics & therapeutic systems requires special care & quality assurance for the tests performed in this department. The most important tests performed routinely in the Blood Bank are as follows; • ABO Blood Group Detection • Cross Match • Antibody Screening & Identification • DAT / IAT • Blood Screening for Infectious Diseases • Minor Blood Group Detection e.t.c. ABO Blood Group is performed generally on slide, which is not recommended nor the results are reliable and there are chances to miss weak reactions while grading of reactions is also not possible. The Tube Technique is although acceptable by the AABB & WHO but the tests performed by this method (with all the SOPs, if followed) are very lengthy procedures (for cross match, requires 30-40 minutes for 90% & 60 minutes for 95% sensitization respectively), requires trained staff. The procedures are different for all the parameters and it is very difficult to handle large batches. Result interpretations are very technical and the weak reactions require microscopy. Whereas the results are never stable nor can be scanned or saved. Exposure to blood borne diseases is very common. Introducing Gel Technology, the tests performed by this technique are more sensitive (can detect even 0.1 I.U/ml antibodies), requires less time (gives 95% sensitization in just 15 minutes), quite simple, with almost identical test procedures, requires less labor with less chances to exposure of blood borne diseases, easy to handle large batches using the Gel cards and easy result interpretations. It can even be performed on fully automated analyzers & the results can be interfaced, scanned, copied & saved on computers for long time. DiaMed introduces to the only FDA approved; WHO recommended ID-Micro Typing System including ID-Centrifuge, ID-Incubator & ID-Pipetor with Sephacryl S 200 Gel. DiaMed offers a wide variety of Gel Cards for different parameters, reagents, consumables and Anti-sera along with semi-automated to fully automated analyzers along with interfacing software and a wide range of accessories of ID-Micro Typing System.
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Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258
DiaMed ID-Micro Typing System
LIMITATIONS WITH CONVENTATIONAL TUBE TECHNIQUES a) Washing required. b) Microscopy required. c) Less sensitive. Detects antibody level of more than 0.5 (500 IgG molecules) I.U/ml in serum/plasma. d) No built-in controls for validation. e) Difficult & lengthy procedure. f) More staff required. g) Interpretation difficult. h) Difficult to handle large batches. i) Each tube gives single phase reaction. j) Large sample volumes. k) Test procedures not identical. l) No wide range of test combinations. m) Reactions not stable. n) Reactions cannot be photocopied / scan. o) Shelf life of results limited. p) Computer interface not possible. q) No automation. r) Less laboratory safety. s) More time required. AN ADVANCEMENT; “GEL TECHNOLOGY”
DiaMed ID-MICRO TYPING SYSTEM a) No microscopy is required. b) No wash IAT principle. c) Highly sensitive. Can detect less than 0.1 (100 IgG molecules) I.U/ml antibodies in serum/plasma. d) This prevents minor transfusion reactions. e) Built-in control validation. f) Simple and rapid to perform. g) Less labor intensive. h) Easy and standardized interpretations. i) Easy grading for positive results. j) Easy handling of large batches. k) Biphasic reaction. l) Small sample volumes. m) Identical test procedures. n) Wide range of test combinations. o) Standardized reactions. p) Stable reactions. q) Reactions can be photocopied / scan. r) Long shelf life. s) Computer interfacing. t) Automation. u) Enhanced laboratory safety.
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Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258
DiaMed ID-Micro Typing System
BRIEF COMPARISION BETWEEN GEL TECHNOLOGY & CONVENTIONAL METHOD Parameters
Conventional Tube Technique
Microscopy
No, agglutinins are trapped in the Gel matrix thus microscopy is never required
Washing Step
No, washing is not required
Incubation Time for Cross match
15 minutes for 95% sensitization
Controls
Built-in controls are available
Parallel controls are not possible
Labor
Less labor intensive
More labor intensive
Detection of week D
Easy
Difficult
Test procedures
Easy & almost identical procedures
Test procedures vary from test to test and sometimes is difficult
Handling
Easy to handle large batches
Difficult to handle large batches
Result Interpretation
Very easy & results can even be photocopied
Difficult for inexperienced workers. Needs skills.
Grading
Very Easy
Not very easy, requires experienced workers
Disposal
Easy
Difficult
Cross Match
Quick procedure
Lengthy procedure
Contact with infectious material
Less chances due to unique disposable cards Easy to keep records, ID-Card can be kept for 48 hours at room temperature & for up to 2 weeks at 2 - 4 OC Latest / Advanced 3rd generation test
More chances. Careful handling is required.
Automation
Can be fully automated
Always manual
Test interpretation
Visual interpretation & the Results can also be interpreted by automated card readers
Needs microscopy and interpretation of critical results are difficult
Test result record
Advancement
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DiaMed ID-Micro typing System
Yes, it requires microscopy Yes, 3 times washing of Red Cells is recommended 30 – 40 minutes for 90% sensitization. 60 minutes for 95% sensitization
Difficult to keep physical records. Old & traditional procedures
Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258
DiaMed ID-Micro Typing System
GEL HISTORY In The Early 1980s, Dr. Yves Lapierre (of France) Developed The Gel Test Aim ….. • To Stabilize The Agglutination Reaction • To Standardized & to Reduce the False-Negative Results • To Create a Simple / Easier way to Interpret Reactions • Lapierre Selected Sephadex G 100 (Instead Of G 25) Gel as the Best Material to Separate and Stabilize Red Cell Agglutination Reactions So….. • 1984 First Gel Result • 1985 First Patent • 1987 Field Testing • 1988 First Kit • 1994 FDA approved (SEPHACRYL S 200) to “DiaMed Company”
DIFFERENT TYPES OF GELS • • • • • • •
SEPHACRYL S 200 (FDA approved & AABB recommended) GELATINE, POLYACRYLAMIDE SILICA BEADS FICOLL, PERCOLL PHALATE ESTERS DEXTRAN GELS SEPHADEX G 100 SUPERFINE
THINGS INTO CONSIDERATION • • • • •
Shape of the cards Volume of gel Nature of plastic & scaling Selection of reagents & media New cards configuration
“DiaMed” - FDA APPROVED • • • • •
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ID-Micro Typing System ID-Centrifuge ID-Incubator ID-Pipetor Gel (Sphacryl S 200)
Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258
DiaMed ID-Micro Typing System
CHARACTERISTICS OF DiaMed Gel Cards • • • • • • • •
Gel Type: Sephacryl S 200 Gel. Gel Sensitivity: 0.1 I.U/ml Gel Spheres Size: 30 - 150 Micron. Inert Particle Distance : 5 - 40 Micron Size. Preservative: Sodium Azide Column Size: 15mm Long X 4mm Wide Gel Quantity: 35µl (75 %) Specific Reagent / Anti- Sera: 25 %
PRINCIPLE OF THE GEL TEST • • •
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75% packed gel and 25% liquid (anti sera). Ag. & Ab. Reaction leads to formation of agglutinates. Gel column allow smaller agglutinates to pass downwards depending on their sizes. Larger agglutinates remains near the top of the gel interface. Un-agglutinated cells pass to the base of the micro-tube to form a button.
TYPES OF GEL • • •
NEUTRAL GEL SPECIFIC GELS ANTIGLOBULIN GELS
WIDE ARRAY OF DiaMed ID-CARDS ID-LISS/COOMBS CARDS • DAT • IAT • “6” CROSS MATCH • ANTIBODY SCREENING • ANTIBODY IDENTIFICATION • DU TEST by IAT • ANTIBODY TITRATION • AUTO CONTROL COMPLETE CROSS MATCH • A-B-D CONFIRMATION. • ENZYME AG. / AB. SCREENING & IDENTIFICATION • AHG / COOMBS • AUTO-CONTROL
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Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258
DiaMed ID-Micro Typing System
ABO/Rh & MINOR BLOOD GROUP CARDS • FORWARD GROUPING • FORWARD & REVERSE GROUPING • Rh-D DETECTION • REVERSE GROUPING FOR CONFIRMATION OF ABO • TO CONFIRM A1 & A2 • MINOR BLOOD GROUPING CARDS • BUILT IN CONTROLS
A CHOICE OF OTHER DiaMed ID-CARDS PNH, SYPHILIS, SICKLE CELL, FETOMATERNAL HEMORRHAGE,DIRECT COOMBS CLASSIFICATION, PLATELETS ANTIBODIES, HEPARIN ANTIBODIES, NEW BORN CARDS, WEAK D DETECTION CARDS, PARTIAL D TYPING, ETC.
SEDIMENTATION GRADIENT PRINCIPAL
Gel Matrix.
Centrifuge is dedicated at approximately 85g ± 1).
Minimum Gravity required for red Cell movement is 80 g for 10 Min.
Unbound IgG proteins lack the weight necessary to be pulled at 85g.
RESULT INTERPRETATION •
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Reactions in the gel are read by examining the front and back of the card. If hemolysis is seen in the micro tube after incubation in the IAT, it should be interpreted as positive.
Sind Medical Stores – DiaMed Division Phone: 021-4521629, 042-5169547, 0333-2109258