Microcuvette - Package Insert
Contents
1. Performance Characteristics Precision Within run precision using the Alere HemoPoint H2 Meter with the Alere HemoPoint H2 Microcuvettes is 2 The precision evaluation was carried out in accordance with NCCLS EP5 A On each of 20 testing days two separate runs with duplicate measurements within each run were carried out Three commercially available control materials were used The test was carried out using 6 Alere HemoPoint H2 devices 16 lots of Alere HemoPoint H2 Microcuvettes and 3 operators Correlation Correlation coefficient of the Alere HemoPoint H2 System compared to the NCCLS H15 A3 reference method Venous blood r 0 998 NCCLS EP5 A Alere HemoPoint H2 Microcuvette measured Protocol in Alere HemoPoint H2 device Hgb Low 8 0 g dL Within run Precision Swr 0 058 g dL CV 0 7 Total Precision Sr 0 122 g dL CV 1 5 Hgb Normal 11 8 g dL Within run Precision Swr 0 070 g dL CV 0 6 Total Precision Sr 0 162 g dL CV 1 4 Hgb High 15 7 g dL Within run Precision Swr 0 087 g dL CV 0 6 Total Precision St 0 174 g dL CV 1 2 Day to Day Precision 8 0 g dL SD 0 111 g dL CV 1 4 11 8 g dL SD 0 176 g dL CV 1 5 15 7 g dL SD 0 179 g dL CV 1 1 Alere HemoPoint H2 System Alere HemoPoint H2 microcuvettes measured in Alere HemoPoint H2 device Regression line and correlation 1 Y 0 2929 1 0086x coefficients compared to NCCLS 2 R 0 998 H15A3 refe2. anticoagulants preferably in solid form to avoid dilutional effects Venous and arterial blood samples may be used if the blood collected is not more than 24 hours old and the samples have been stored refrigerated 35 46 F 2 8 C Prepare stored samples for measurement as follows 1 Remove sample tube from the refrigerator and bring it to room temperature 2 Mix the sample tube well i e by a mechanical rotator or hand inversion at least 10 times Procedure Refer to the Alere HemoPoint H2 User s Guide for proper use of the meter Materials Provided Alere HemoPoint H2 Microcuvettes Ref No 80549 Materials Required But Not Provided Alere HemoPoint H2 Meter Alere HemoPoint H2 Control Cuvette optional Alere Hemoglobin Controls Ref No 88772 optional Disposable pipettes venous or arterial blood only Plastic film venous or arterial blood only Lint free material Instructions For Use Capillary 1 Make sure that the meter is ready for use 2 Make sure that your patient is sitting comfortably 3 There should be a good blood circulation in the hand from which you wish to take blood i e it should be warm and relaxed 4 Lightly massage the fingers in order to stimulate circulation 5 Disinfect the puncture site and allow to dry 6 Take out a Alere HemoPoint H2 Microcuvette from the container and close the lid immediately 7 Press lightly on the fingertip and puncture with a
3. middle of the drop of blood and let the cavity fill in one step In case of air bubbles in the optical eye discard the Alere HemoPoint H2 Microcuvette and take another sample using a new Alere HemoPoint H2 Microcuvette 7 In order to avoid contamination of the Alere HemoPoint H2 Microcuvette holder remove surplus blood from the outside of the Alere HemoPoint H2 Microcuvette 8 The Alere HemoPoint H2 Microcuvette sample prepared in this way can now be measured immediately or within 10 minutes at the latest Limitations of the Procedure 1 The Alere HemoPoint H2 Microcuvette sample can be measured immediately or within 10 minutes at the latest otherwise false results may be obtained 2 Air bubbles in the optical eye caused by inadequate filling of the Alere HemoPoint H2 Microcuvette cavity may cause false results Discard the Alere HemoPoint H2 Microcuvette and take another sample using a new Alere HemoPoint H2 Microcuvette 3 Ensure that you do not hold the Alere HemoPoint H2 Microcuvette at its filling end because this may contaminate the optical eye 4 In order to avoid contamination of the Alere HemoPoint H2 Microcuvette holder remove surplus blood from the outside of the Alere HemoPoint H2 Microcuvette 5 All results above 23 5 g dL or equivalent must be confirmed by laboratory method 6 Sulfhemoglobin is not measured by this method 7 Carboxyhemoglobin and turbidity due to leukocytosis or
4. w w sodium nitrite and 20 w w non reactive ingredients Warnings and Precautions Alere HemoPoint H2 Microcuvettes are designed for in vitro diagnostic use only The reagents which coat the inner walls of the Alere HemoPoint H2 Microcuvettes are harmful and must not be swallowed Wear suitable protection gloves at all times when handling blood samples Please note that all human blood samples or products must be handled as potentially infectious waste per your local regulations Storage Alere HemoPoint H2 Microcuvettes are to be stored solely in the original container and at room temperature 59 86 F 15 30 C DO NOT refrigerate Use Alere HemoPoint H2 Microcuvettes within 3 months after opening container Document the initial opening date on the container label in the space provided Only remove one Alere HemoPoint H2 Microcuvette at a time from the container and then immediately close the lid The Alere HemoPoint H2 Microcuvettes are analyzed optically in the Alere HemoPoint H2 Meter Measurement light must pass through the sample Alere HemoPoint H2 Microcuvette to the photo detector with the least possible interference It is therefore crucial not to touch the optical eye of the Alere HemoPoint H2 Microcuvette with fingers dirty or sharp objects Sample Collection and Preparation The Alere HemoPoint H2 Meter can be used with capillary venous or arterial blood Use EDTA heparin or heparin fluoride as
5. AL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION LOSS OF BUSINESS PROFITS DATA OR REVENUE EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE KINDS OF DAMAGES MIGHT RESULT The Limited Warranty above shall not apply if the Customer has subjected the Product to physical abuse misuse abnormal use use inconsistent with the Product Manual or Insert fraud tampering unusual physical stress negligence or accidents Any warranty claim by Customer pursuant to the Limited Warranty shall be made in writing within the applicable Limited Warranty period Distributed by Alere North America Inc 30 South Keller Road Suite 100 Orlando FL 32810 www alere com Made in Germany 2012 Alere All rights reserved The Alere Logo and Alere are trademarks of the Alere group of companies HemoPoint is a trademark of Stanbio Laboratory L P under license PN 26274 Rev B 2012 09
6. HemoPoint H2 Microcuvettes For the quantitative determination of hemoglobin in capillary venous or arterial whole blood CLIA Complexity Waived Intended Use The Alere HemoPoint H2 Microcuvettes are intended to be used in the Alere HemoPoint H2 Meter The reagents microcuvettes and the Alere HemoPoint H2 Meter form an analytical system Summary and Principle The Alere HemoPoint H2 System is intended to be used for the quantitative determination of hemoglobin Hgb concentration in human blood It consists of a meter instrument and individual single use microcuvettes filled with reagents Using the Alere HemoPoint H2 Microcuvette a small amount of capillary venous or arterial blood is taken up by capillary action The Alere HemoPoint H2 Microcuvettes are intended to be used once only and must be disposed of after use as potentially infectious waste in accordance with the current regulations applicable to your establishment The Alere HemoPoint H2 System is designed for use in medical practices and in clinical laboratories to assist in medical diagnostics In addition it can be used in emergency and intensive care units and in medical facilities such as blood donor sessions and blood banks Blood sampling and operating the Alere HemoPoint H2 System should be carried out by trained personnel with sound knowledge of the system The recognized reference method for total hemoglobin is the cyanmethemoglobin metho
7. d which is also known as the cyanhemoglobin method The blood sample is diluted 1 251 with a reagent buffering solution Here the erythrocytes are hemolyzed and the bivalent iron in oxyhemoglobin and desoxyhemoglobin are oxidized by the reagent potassium hexacyanoferrate Ill to trivalent iron and so converted to methemoglobin Together with cyanide ions which are also contained in the reagents the methemoglobin forms a stable colored complex namely cyanmethemoglobin This has a wide absorption maximum at 540 nm This absorption is proportional to the Hgb concentration In 1966 Vanzetti suggested to replace KCN by NaN3 and thus he was able to reduce the toxicity of the reagent mixture considerably Vanzetti s method is also known as the azide methemoglobin method A modified azide methemoglobin method is used in the Alere HemoPoint H2 System Principles of the Procedure In the Alere HemoPoint H2 System the use of Alere HemoPoint H2 Microcuvettes with short light pathways makes it possible to analyze undiluted blood The filled Alere HemoPoint H2 Microcuvette is inserted into the Alere HemoPoint H2 Meter the color produced by the chemical reaction in the Alere HemoPoint H2 Microcuvette is measured and the hemoglobin level is calculated and displayed For this purpose light is directed through the blood sample and the absorption is measured From the amount of light absorbed by the sample the concentration of
8. hyperlipemia do not interfere 8 Always place Alere HemoPoint H2 Microcuvette right side up in holder Placing the Alere HemoPoint H2 Microcuvette upside down can lead to erroneous results Expected Values 5678 The following hemoglobin values are considered normal Adult males 13 0 18 0 g dL Adult females 11 0 16 0 g dL Children 11 0 16 0 g dL Infants postnatal 10 0 14 0 g dL Due to a wide range of conditions which affect normal values it is recommended that each laboratory establish its own normal range Quality Control The Alere HemoPoint H2 AutoCheck performs an internal check of the meter s optic system every time the Alere HemoPoint H2 Microcuvette holder is opened If additional regulatory quality control is required in your facility the following checks may be performed 1 If a Alere HemoPoint H2 Control Cuvette was supplied with the Alere HemoPoint H2 Meter it can be used for a simple check of the Alere HemoPoint H2 Meter s calibration 2 Use of external controls to assure that the Alere HemoPoint H2 Microcuvettes and the Alere HemoPoint H2 Meter are performing correctly For this purpose we recommend the use of the Alere Hemoglobin Controls Ref No 88772 Do not use cyanmethemoglobin standards with this test Results The test result is displayed directly on the screen of the Alere HemoPoint H2 Meter No calculations are necessary The test is linear up to 23 5 g dL
9. our local distributor if you have any questions regarding the use of your Alere product You may also contact us at www alere com E Mail Address US 1 866 216 0073 HemoPoint H2 Support alere com Region Phone Alere Customer Service Contact the following Alere Service Care Center or your local distributor for order and billing assistance You may also contact us at www alere com Phone E Mail Address 1 877 441 7440 clientservices alere com Limited Warranty FOR THE APPLICABLE WARRANTY PERIOD ALERE WARRANTS THAT EACH PRODUCT SHALL BE I OF GOOD QUALITY AND FREE OF MATERIAL DEFECTS ll FUNCTION IN ACCORDANCE WITH THE MATERIAL SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL AND Ill APPROVED BY THE PROPER GOVERNMENTAL AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR INTENDED USE the LIMITED WARRANTY IF THE PRODUCT FAILS TO MEET THE REQUIREMENTS OF THE LIMITED WARRANTY THEN AS CUSTOMER S SOLE REMEDY ALERE SHALL EITHER REPAIR OR REPLACE AT ALERE S DISCRETION THE PRODUCT EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION ALERE DISCLAIMS ANY AND ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NON INFRINGEMENT REGARDING THE PRODUCT ALERE S MAXIMUM LIABILITY WITH ANY CUSTOMER CLAIM SHALL NOT EXCEED THE NET PRODUCT PRICE PAID BY CUSTOMER NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL INCIDENT
10. rence method g dL 3 N 100 duplicate measurements venous blood 4 Summary of results References 1 NCCLS Reference and selected procedures for the quantitative determination of hemoglobin in blood second edition approved standard NCCLS Document H15 A3 2000 2 G Vanzetti An azide methemoglobin method for hemoglobin determination in blood Am J Lab amp Clin Med 67 1966 116 3 Alere HemoPoint H2 Meter User Manual Alere North America Orlando Florida USA 4 Fandek N Moreau D Newell KC Ofner A eds Clinical Laboratory Tests Values and Implications 2nd ed Springhouse Corporation 1995 328p 5 DeMott Wayne R Tilzer Lowell L Hematology In Jacobs DS DeMott WR Finley PR Horvat RT Kasten Jr BL Tilzer LL eds Laboratory Test Handbook Hudson Lexi comp 1992 517 626 6 Wallach J eds Interpretation of Diagnostic Tests A Synopsis of Laboratory Medicine 4th ed Boston Toronto Little Brown and Co 1986 6p Te Painter Pennell C Cope June Y Smith Jane L Appendix In Burtis CA Ashwood ER eds Tietz Textbook of Clinical Chemistry Philadelphia WB Saunders 1994 2161 2217 8 Tietz N ed Clinical Guide To Laboratory Tests WB Saunders 1983 258 259 9 NCCLS Evaluation of Precision Performance of Clinical Chemistry Devices Document EP5 A Vol 19 No 2 February 1999 Alere Technical Support Contact one of the following Alere Technical Support Care Centers or y
11. suitable sampling device on the side of the fingertip 8 Blot away the first drop of blood then if necessary press gently once again to get a 2nd drop of blood which is large enough to fill the Alere HemoPoint H2 Microcuvette completely Avoid milking the finger 9 Hold the center of the Alere HemoPoint H2 Microcuvette in the middle of the drop of blood and let the cavity fill in one step In case of air bubbles in the optical eye discard the Alere HemoPoint H2 Microcuvette and take another sample using a new Alere HemoPoint H2 Microcuvette 10 In order to avoid contamination of the Alere HemoPoint H2 Microcuvette holder remove surplus blood from the outside of the Alere HemoPoint H2 Microcuvette 11 The Alere HemoPoint H2 Microcuvette sample prepared in this way can now be measured immediately or within 10 minutes at the latest Instructions For Use Venous or Arterial 1 Make sure that the meter is ready for use See the Alere HemoPoint H2 User Manual for additional information 2 Remove sample tube from the refrigerator and bring it to room temperature 3 Mix the sample tube well i e by a mechanical rotator or mixing by hand at least 10 times 4 Take out a Alere HemoPoint H2 Microcuvette from the container and close the lid immediately 5 Pipette a sufficient drop of blood on a non absorbent material e g plastic film 6 Hold the center of the Alere HemoPoint H2 Microcuvette in the
12. the hemoglobin in the Alere HemoPoint H2 Microcuvette can be calculated using the Beers Lambert Law Light emitting diodes LED s are used as light sources and a photodiode is used to detect the light The light emitting diodes utilize the central wavelengths 570 nm for measurement and 880 nm for turbidity compensation The Alere HemoPoint H2 Microcuvette The plastic Alere HemoPoint H2 Microcuvette consists of a clear body with a cavity which takes up approximately 8 uL of blood which combines with the dry reagent chemistry The optical distance between the Alere HemoPoint H2 Microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples The Chemistry Principle In order to use the azide methemoglobin method in undiluted blood three reagents are necessary sodium deoxycholate dissolves and disperses the cell walls of the red blood corpuscles Hence the hemoglobin formerly contained in the erythrocytes is now available free in the solution The bivalent iron of the oxyhemoglobin and the deoxyhemoglobin become oxidized by sodium nitrite NaNO2 to trivalent iron in methemoglobin Existing and formed methemoglobin and azide ions from sodium azide NaN3 form a colored complex which exhibits maximal absorption at 540 and 575 nm and hence it can be quantitatively determined photometrically Reagents Alere HemoPoint H2 Microcuvettes 40 w w sodium deoxycholate 20 sodium azide 20
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