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Analytical Control Systems, Inc.

Hemoglobin Assays and Controls

The normal level glycohemoglobin product is a stabilized oxy hemoglobin control with values between 6.0% and 8.0%. The elevated control has a glycohemoglobin level between 11% and 15%. The values are assigned by electrophoresis and affinity chromatography methods. These product perform very well in weak cation exchange HPLC. Stability is excellent—– at least 10 days after reconstitution, 21 days frozen after reconstitution and for two years as a lyophilized powder.

• HC-101 6X0.5 ml normal controls
• HC-101EL 6X0.5 ml elevated controls

Variant Hemoglobin Control, AFSC & NAFSC

ACS’s Variant Hemoglobin Control, AFSC and NAFSC are useful controls for any electrophoresis screening procedure where variant hemoglobins are expected. The stabilized oxyhemoglobin based AFSC control has values for A, F, S, and C of approximately 40%, 25%, 20% and 15% respectively and the stabilized, oxyhemoglobin based NAFSC control has values for N-Baltimore, A, F,S, and C of approximately 34%, 44%, 6%, 6% and 9% respectively. The products are stable for 10 days after reconstitution, for 21 days frozen after reconstitution and for two years unreconstituted and refrigerated.

HC-102 6X0.5 ml AFSC Control HC-102N 6X0.5 ml NAFSC Control

Variant Hemoglobin Control, HAFSC

The blocks and empty spaces represent the genes for alpha-globin synthesis. Hemoglobin H represents an excess beta chain production and is a hemoglobin tetramer of beta chains. This is caused by a decreased production of alpha-globin chains causing a production mismatch. Because the amount of Hemoglobin H is rather low in heterozygous patients, ACS’s control is formulated with A, F, S and C and is rather out of balance with low (but detectable) H, markedly high A, and lower F, S and C values. This control allows the laboratory to test their procedures to determine if they can detect Hemoglobin H thereby helping in the detection of alpha thalassemia. The product is stable for 10 days after reconstitution, for 21 days frozen after reconstitution and for two years unreconstituted and refrigerated.

HC-102H 6X0.5 ml HAFSC Control

Variant Hemoglobin Control, AF

ACS’s Variant Hemoglobin Control, AF is useful in laboratories doing hemoglobin electrophoresis screening of newborns. The control performs on both alkaline electrophoresis and acid citrate agar media. The stabilized, oxyhemoglobin based Variant Hemoglobin Control, AF has values for A and F of about 60% and 40%, respectively. The stability is assured for at least 10 days reconstituted, 21 days frozen after reconstitution and the control has a two year refrigerated shelf life when unreconstituted.

HC-103 6X0.5 ml

Variant Hemoglobin Control, AS

ACS’s Variant Hemoglobin Control, AS is useful in laboratory screenings for sickle cell trait and disease. The control performs on both alkaline electrophoresis and acid citrate agar media. The stabilized, oxyhemoglobin based Variant Hemoglobin Control, AS has values for A and S of about 60% and 40% respectively. Stability is assured for at least 10 days reconstituted, 21 days frozen after reconstitution and the control has a two year refrigerated shelf life when unreconstituted.

HC-104 6X0.5 ml

ACS’s Variant Hemoglobin Control, AC is useful in confirming the presence of variant hemoglobin C in populations where C and E occur and in the presence of other hemoglobins such as elevated hemoglobin A₂. The control performs on both alkaline electrophoresis and acid citrate agar media. The stabilized, oxyhemoglobin based Variant Hemoglobin Control, AC has values for A and C of about 60% and 40% respectively. Stability is assured for at least 10 days reconstituted, 21 days frozen after reconstitution and the control has a two year refrigerated shelf life when unreconstituted.

HC-105 6X0.5 ml

The measurement of hemoglobin A₂ is important in the diagnosis of thalessemia. The most commonly used diagnostic procedures are alkaline cellulose electrophoresis and column chromatography. ACS’s normal and elevated A₂ controls are specifically prepared to be useful in both procedures. The total hemoglobin is adjusted to about 4.0 gm/dl and the normal control contains from 1.5%-2.5% A₂, while the elevated contains 3.5% to 5.0%. The reconstituted controls can be applied directly in either procedure without further dilution. For procedures which measure A₂ in the presence of hemoglobin S, please inquire. The bulk product may also be order OEM to dispense and lyophilized on location (minimum 1 liter).

• HC-111 6X0.5 ml normal
• HC-112 6X0.5 ml elevated

Hemoglobin E is a fairly rare hemoglobinopathy in the United States. However, it occurs in the 30– 50 million person range in Asia, mainly among southeast Asian peoples. Therefore, a high incidence of hemoglobin E is to be expected among such populations both in America and in Europe. Because of the overlap between hemoglobin E and beta thalassemia, there may be severe clinical symptoms amongst heterozygous E patients due to the combined hemoglobinopathies (E & beta thalassemia). Due to the electrophoresis mobility properties, structural stability and other physical characteristics of these hemoglobins, good technique and appropriate controls are essential in the correct identification of these hemoglobinopathies. Care also should be taken to properly identify and quantitate hemoglobin A₂ when thalassemia is suspected. ACS makes a heterozygous quality control sample. The donor AE has been carefully tested and properly identified to assure analysts that a proper E hemoglobin in present.

• HC-117 6X0.5 ml

Variant Hemoglobin Controls, AFC & AFS

ACS’s Variant Hemoglobin Control, AFC is useful in confirming the presence of variant hemoglobin C in populations where C and E occur and in the presence of other hemoglobins such as elevated hemoglobin A₂. ACS’s Variant Hemoglobin Control, AFS is useful in laboratories screening for sickle cell trait and disease. The controls perform on both alkaline electrophoresis and acid citrate agar mediums. AFC and AFS are stabilized, oxyhemoglobin based Variant Hemoglobin Controls. Stability is assured for at least 10 days reconstituted, 21 days frozen after reconstitution and the control has a two year refrigerated shelf life when unreconstituted.

• HC-118 AFS 6X0.5 ml
• HC-119 AFC 6X0.5 ml

Although both hemoglobin D disease and trait hemoglobin AD are extremely rare, the importance of using controls is highlighted by the fact that hemoglobin S and hemoglobin D migrate similarly upon alkaline (pH 8.6) electrophoresis. This is so because both hemoglobin S and D arise from single, similarly charged amino acid substitutions on the beta-globin chain. The substitution is at position six in hemoglobin S and 121 for hemoglobin D. Hemoglobin D doesn’t sickle using the standard laboratory techniques but does have a higher than normal oxygen affinity. Using selective laboratory techniques and controls allows the correct diagnosis of hemoglobin D trait or disease.

• HC-120 6X0.5 ml

ACS’s Variant Hemoglobin Control, Fractions contains one vial each of AS, AC, AF and A₂ stabilized, oxyhemoglobin based Variant Hemoglobin Controls. AC helps to confirm the presence of variant hemoglobin C in populations where C and E occur. The measurement of A₂ is important in the diagnosis of thalessemia. AS is useful in laboratories screening for sickle cell trait and disease. AF aids laboratories involved in the screening of newborns. The controls perform on both alkaline electrophoresis and acid citrate agar media. Stability is assured for at least 10 days reconstituted, 21 days frozen after reconstitution and the control has a two year refrigerated shelf life when unreconstituted.

• HC-121 AS 1X0.5 ml, AF 1X0.5 ml, AC 1X0.5 ml, A₂ 1X0.5 ml

ACS Quik-Sep® Hemoglobin F Assay is designed for accurate quantitation of adult hemoglobin F in ranges from 2% to 40% by alkali denaturation. The ACS Hemoglobin Assay is based on the ability of hemoglobin F to resist denaturation under alkaline conditions. Most hemoglobins can be denatured at a base pH and then precipitated with ammonium sulfate. Fetal hemoglobin remains soluble and can be readily quantified using a standard laboratory spectrophotometer. Accurate measurement can be useful in helping the physician diagnose certain hemoglobinopathies and thalassemias. The Quik-Sep® Kit contains potassium cyanide, cyanmethemoglobin (Drabkin’s reagent), sodium hydroxide, ammonium sulfate and 50 filter columns.

• HK-1050 50 tests Contains: Potassium Cyanide (2%), Cyanmethemoglobin (Drabkin’s) Reagent, Sodium Hydroxide, Ammonium Sulfate, Filter Columns

ACS’s Variant Hemoglobin Control, F is an useful control for alkali denaturation hemoglobin screening. The normal control has an F hemoglobin approximately that of normal patients <2%, while the elevated control has an F hemoglobin level of approximately 8.5%. The control is designed for use on the ACS Quik-Sep® Hemoglobin Assay Kit (alkali denaturation) but performs on both alkaline electrophoresis and acid citrate agar mediums. Stability is assured for at least 10 days. Reconstituted, 21 days frozen after reconstitution and for two years as a lyophilized powder.

HC-106 6X0.5 ml HC-106EL 6X0.5 ml

Hemoglobin, Galactose-1-Phosphate Uridyl Transferase Control, Normal & Depressed

ACS’s Gal-1-PUT Control is hemoglobin based and useful in screening and quantitative assays used to aid the diagnosis of galactosssemia. The Gal-1-PUT Control contains Gal-1-PUT in a stabilized oxyhemoglobin base with either normal or depressed levels of enzyme in normal levels of hemoglobin. Stability is assured for at least 10 days when the control is reconstituted, 21 days frozen after reconstitution and for two years when refrigerated and unreconstituted. Approved OEM customers can order quantities (minimum of 1 liter ) to dispense and lyophilized at their own facilities.

• HC-107 6X0.5 ml Normal Controls
• HC-107DE 6X0.5 ml Depressed Controls
• Both are available OEM as a bulk liquid

ACS’s Hemoglobin based G-6-PDH Control is useful in tests designed to detect G-6-PDH deficiencies and in the management of drug sensitivities related to this deficiency. The controls, normal, intermediate and depressed, consist of stabilized oxyhemoglobin bases and adjusted levels of G-6-PDH. All three controls perform remarkably well in kinetic, visual or fluorescent procedures. Stability is at least 5 days reconstituted, 21 days frozen after reconstitution and two years as a lyophilized powder. The bulk product is available to OEM customers (minimum quantity: 1 liter) to be dispensed and lyophilized in house.

• HC-108 6X0.5 ml Normal Controls
• HC-108IN 6X0.5 ml Intermediate Controls
• HC-108DE 6X0.5 ml Depressed Controls
• All are available OEM as a bulk liquid

ACS’s Total Hemoglobin Control is specifically designed to test the efficacy of hemoglobin tests such as cyanmethemoglobin. These reagents frequently loose their potency and yield inaccurate values as they age. Using a pre-prepared standard control assay will not detect this problem if the hemoglobin is in the measured chemical form before it is added to the reagent. ACS’s Total Hemoglobin Control fully checks assays reagents since it is composed of nearly all oxyhemoglobin. Values can be adjusted to range from very low to well above normal expected values. The higher concentration material can be used as a linearity verifier.

• HC-110 6X3.0 Total Hemoglobin Controls Normal
• HC-110LIN 6X3.0 Linearity Total Hemoglobin Controls
• Total Hemoglobin is available as an OEM bulk liquid

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