Specific Gravity of Blood

medical history and risk assessment for transfusion-transmissible infections
(TTI); technical recommendations on donor selection criteria are summarized
on pp. 6–15 and elaborated in Sections 4 to 7.
Blood donor selection: guidelines on assessing donor suitability for blood donation
was developed in accordance with the WHO guidelines development process,
which requires systematic review of new evidence for key questions and
recommendations, as well as a consideration of programme feasibility and the
cost implications of potential new recommendations. A systematic review of the
published and “grey” literature was conducted covering the period 1995–2011,
and also in 2012 for selected topics. Particular efforts were made to identify
systematic literature reviews and evidence related specifically to blood donor
selection in low- and middle-income countries. Detailed literature search strategies
and the decision-making process for the formulation of recommendations are
available in Annex 3.
High quality evidence on which to base decisions on the suitability of prospective
donors for blood donation is, however, limited or even lacking in relation to many
medical conditions and risk behaviours. Where published evidence is lacking,
recommendations are based on international best practices and the knowledge
and expertise of members of the guideline development group and external
review group in the fields of human physiology, pathology and clinical medicine.
In conditions where emerging evidence suggests that deferral criteria may be
relaxed, a precautionary approach is recommended until good evidence of safety
becomes available. It is anticipated that the recommendations in this document
will remain valid until 2017 when a review of these guidelines will be undertaken
to explore any new evidence, particularly in relation to controversial issues or
where changes in practice may be appropriate.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

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Blood donor screening mandates hemoglobin (Hb) estimation as the only laboratory test to be performed prior to the process of blood donation. The purpose of this test is to serve as an important public health sentinel. As the Hb of a blood donor drops by 1–1.5 g/dL after donating a single unit of whole blood, an appropriate pre-donation test may mitigate the possibilities of rendering the blood donor anemic. A good test is also a certitude of good quality of blood components, which has an explicit implication on the recipient’s health.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

The cutoff Hb criteria have been designed for different populations world over to maximize donor safety and balance for adequate availability (Table 1). Reason for diversity in the criteria is variability of Hb level with age, race, sex,1 altitude, cigarette smoking and site from which the sample has been taken.2 These regulations, however do not specify the method of Hb estimation, vascular compartment (capillary or venous), specimen type and donor position (standing or recumbent) to which they apply. This article aims to review various regulatory guidelines, variables that affect the measurements and validated technologies for Hb screening of blood donors. It is pertinent to understand the characteristics of performance of various techniques for assessing their applicability and reliability as tests for Hb screening of blood donors (Table 2).

Table 1 Hb screening criteria in various guidelines

Abbreviations: Hb, hemoglobin; FDA, Food and Drug Administration; AABB, American Association of Blood Banks; hct, hematocrit; EU, European Union.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Table 2 Measures of performance of Hb screening tests

Abbreviations: Hb, hemoglobin; CV, coefficient of variation; SD, standard deviation.

Factors affecting the Hb test result

Source of sample

The source of the blood sample is the most important variable for the accuracy of a technique and critical determinant of donor eligibility in borderline cases. The inherent variations are due to anatomical and technical reasons. The major source of blood from a finger stick is the loop capillaries, the concentration of which fluctuates with skin temperature, depth of skin penetration and dilution by extracellular tissue fluid exuded due to skin pressure. Poor reproducibility of measurements has been reported even from different fingers of same subject due to inconsistencies in the process of sample acquisition, such as the size and style of the lancet used, the manner in which the lancet is applied and innate differences in individual blood droplets from capillaries.10 The studies comparing Hb levels through blood obtained from various anatomical sites have been listed  Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Table 3 Studies comparing Hb and hct levels in blood obtained from various anatomical sites

Abbreviations: Hb, hemoglobin; hct, hematocrit; SD, standard deviation; ELS, ear lobe sample; FS: finger-stick sample; VS, venous sample.

Ear lobe puncture, which is now obsolete, was previously used to obtain blood for the specific gravity determination by the copper sulfate method. The reasons stated in its favor were donor comfort and a diminished potential for infection since fingers are used in several ways in which ear lobes are not.11 However, blood specimens were found to have increased hematocrit (hct) and Hb concentration attributed to variance in flow characteristics of plasma, leading to increased relative concentration of red cells in this region.12 Ear lobe samples thus have been found to overestimate the Hb concentration by as high as 2 g/dL and show higher variance than blood collected simultaneously from the fingertip.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Finger stick capillary versus venous sample (VS)

There is a huge disagreement on the use of capillary blood for Hb estimation of blood donors because it is highly operator dependent with subsequently low precision and it has lower acceptance by donors due to the associated pain and discomfort. Conflicting data have been reported on the simultaneous determination of Hb on capillary and VSs. Two studies in the past reported no significant difference between finger-stick sample and VS.15,22 A large numbers of studies have subsequently reported an overestimation of Hb with capillary blood.2,14,16 Mendrone et al23 and Bahadur et al24 have reported an overestimation of venous Hb values by capillary screening using HemoCue by ~7–8 g/L. Several plausible reasons have been suggested for this. One is that capillary blood has an arterial source due to which Hb levels are higher than venous.25 Others suggest that higher capillary Hb levels are due to hemoconcentration caused by the influence of posture.18,26

A study by Darragh et al17 has shown contrasting results. They found that mean venous Hb levels are underestimated by capillary screening, on the basis of which the thresholds for whole blood donation have recently been lowered to capillary Hb levels of at least 120 and 130 g/L for females and males, respectively, in Ireland. On the same lines, another study from Ireland for Hb determinations from blood donors not meeting donation criteria (≥12.5 g/dL in women; ≥13.5 g/dL in males) also found that venous Hb levels were consistently higher than capillary levels when the Hb levels were in the lower side of the normal range. A capillary Hb level of 12.0 g/dL (for females) or 13.0 g/dL (for males) is substantively equivalent to a venous Hb level of at least 0.5 g/dL higher, permitting blood donation.27 A recent study by Ardin et al28 has also reported a falsely low Hb estimation by capillary blood, showing a bias of 0.53±0.81 g/dL from venous blood.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Most studies comparing capillary and venous blood have used different techniques for Hb estimation (hemoglobinometer for capillary and automated hematology analyzer for venous blood).2,16,17,19 Therefore, this may not be a true comparison as there is an inherent component of bias due to the technique used. Moreover, deriving a firm inference for the nature of relationship for blood obtained from different sources is complex as it also varies with sex and the underlying Hb level. Ziemann et al19 using capillary blood detected a low sensitivity (41.3% and 18.6% for females and males, respectively) for detecting donors with venous Hb values just below the cutoff guidelines, in contrast to a high sensitivity (97.4%) for detecting donors with venous Hb levels <110 g/L. The results from a multi-centric study showed that finger-stick Hb was higher than venous Hb in the higher side of the clinical range, but lower in the lower side of the range, particularly in female donors with absent iron stores. The study found that even though finger-stick Hb is a good predictor of venous Hb, females with a low–normal Hb and anemic donors are likely to be incorrectly accepted by this method.29 Similarly, in a study of 36,258 paired samples, Tong et al27 demonstrated that at the lower end of the normal range of Hb concentrations, venous Hb levels were higher than capillary levels (1.07 g/dL in males and 0.67 g/dL in females). As the Hb levels increased, the difference between the venous and the capillary measurements reversed.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Capillary blood is said to be an estimate rather than a measure of the true venous Hb, and cutoff values in the guidelines have been set on the basis of venous Hb levels. Obtaining VS is a prerequisite for accuracy but is non-pragmatic because it subjects the donor to another venipuncture, jeopardizing a potential phlebotomy site and adding to the volume of blood withdrawn. Thus, capillary blood must be used for operational purpose, but there is a need to emphasize on the efforts to increase the accuracy of capillary Hb measurements by identifying the variables that influence the results in a particular setting.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

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Postural effect

Standing causes hemoconcentration as fluids pool in the lower extremities and consequently intravascular fluids shift into the interstitial spaces. There is an apparent hemodilution due to flow of extravascular fluid into the circulation when a person assumes a recumbent position after sitting or standing.30 In addition, there is some hemodilution to compensate for the volume depletion due to the phlebotomy, which results in lowering of the mean venous hct. Thus, post-donation VSs tend to show lowered Hb and hct as compared to those obtained before phlebotomy. Nevertheless, obtaining a pre-donation VS is non-pragmatic as an additional venipuncture is not acceptable to most blood donors and accessing the blood collection set may risk the blood unit to bacterial contamination. Wood et al14 found a difference of 1.2% in hct, and Boulton et al31 have found a difference of 0.35 g/dL in Hb levels of pre-donation and post-donation samples.

Biological variability

Besides age, sex and race, the Hb level varies with smoking and physical activity. Black people have a ~1 g/dL lower Hb level, whereas smokers and those living at a higher altitude have a higher Hb level. Shifts in intravascular fluids also lead to diurnal and seasonal variation in Hb levels. Mean hct has been found to be 3% lower in summer as compared to winter due to hemodilution.32 Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Methods for Hb estimation in blood donors

The venous Hb level of a donor drops by 1–1.5 g/dL after blood donation. Thus, a screening test should be sensitive enough to detect donors with preexisting anemia or who may be rendered anemic after blood donation. Since every single blood unit matters for a blood bank, it should also be able to avoid unnecessary deferrals, should be smoothly incorporable into the operational practices and should have a reasonable cost. Donor discomfort should be minimum, handling should be easy and should be portable so as to be applicable in mobile settings. Several methods for Hb estimation of blood donors have evolved in the last few decades, each having its own set of advantages and disadvantages.

Copper sulfate gravimetric method

This method is based on the estimation of specific gravity of blood, assuming that the donor has normal protein levels. Specific gravity of 1.053 corresponds to an Hb level of 12.5 g/dL. A drop of blood, allowed to fall into a copper sulfate solution of specific gravity 1.053, becomes encased in a sac of copper proteinate, which prevents dispersion of fluid for 15 seconds. If the specific gravity of blood is higher than the solution, the drop will sink or else it will remain suspended for some time. In most cases, this method is capable of estimating Hb within ~0.5 g/dL, which is comparable to a coefficient of variation (CV) of 2%.33 Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Although the method has withstood the test of time in ease of performance and cost, it is criticized for having a subjective end point. This test also gives false-negative results, very commonly leading to large amounts of inappropriate donor deferrals (50%–70%).34,35 Common sources of error leading to determination of falsely low Hb are incorporation of air bubbles and the use of an inadequate height for dropping the blood. Several studies have advocated the implementation of a supplementary method, such as microhematocrit or portable hemoglobinometer (PH), in order to recover the inappropriate deferrals.22,34–36 Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Proteins other than Hb are also nonspecifically precipitated by copper sulfate. This may lead to determination of falsely high values of Hb if the subject has abnormally raised protein levels. For each gram of protein increased above the level of 7.4 g/100 mL, an error of 0.7 g will appear in the calculated Hb concentration. There has been a case wherein a donor with <8 g/dL of Hb passed the copper sulfate screening test due to the hyperproteinemia associated with multiple myeloma.37

Proficiency testing methodology for this method is not well established. Quality control of this method can be done by either testing with several anticoagulated samples with hemoglobin determined by a more accurate method or by a well-calibrated hydrometer. The reagent solution should be changed after every 25 tests as each drop of blood alters the specific gravity due to the protein contained.4 Disposal of biohazardous waste material is another concern and should be carried out as per local legislation.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Spun microhematocrit

This has been suggested as an ancillary test to decide eligibility for blood donors who were found to have low Hb on copper sulfate testing.38 Supplementation by this method for donor screening has been found to retrieve 46%–58% of deferred donors,34,39 salvaging a large amount of blood units. Blood is obtained from another finger after a second prick and collected in a capillary tube with an anticoagulant. It is then centrifuged in a microhematocrit centrifuge, and the percentage of packed red blood cells is estimated using an hct reader. Results show variation with the use of mobile or fixed centrifugation equipment,40 anticoagulant solution41 and the diameter of microhematocrit tube used.42 The quoted CV for this method is 3.6%.43 Although inexpensive and easy to use, it requires time of at least 5–7 minutes, which is a limitation for donor screening. A study to compare its performance with more established methods found that the results did not correlate well with either the cyanmethemoglobin or CuSO4 method.44 Another comparative study from Brazil showed that this method had a sensitivity of 39.5% and specificity of 93.2%. Overall, it had a lesser discriminating power for detecting anemia in prospective female blood donors than the HemoCue 201 system (HemoCue AB, Angelholm, Sweden).23 Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Hemoglobin color scale (HCS)

It was developed in 1995 as an inexpensive, simple alternative, intended for initial screening of anemia in field conditions where elaborate laboratory equipment was not available. The HCS uses a strip of chromatography paper and a standard color chart. The method compares the color of a drop of blood absorbed onto chromatography paper with colors on standard chart, varying from pink to dark red. These colors correspond to Hb levels of 4, 6, 8, 10, 12 and 14 g/dL. Intermediate shades can be identified, allowing Hb levels to be judged to 1 g/dL.45

The method has been found to be useful and convenient for anemia screening in field conditions according to many community studies,46,47 but its accuracy remains questionable. While cost, simplicity and portability add attractive propositions, the method has been found to have very low sensitivity and specificity for screening of Hb prior to blood donation.48 An Indian study has reported 25.2% false results with this method,36 whereas another study from the UK reports that only 46.08% results by this method were accurate.49 Given that the result interpretation by this method is subject dependent, a lot of factors may account for the inaccuracy such as reading of results in dim light and fading of standard cards. Another limitation for use in blood banks is its non-readability for intermediate value, i.e., a Hb value of 12.5 g/dL.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Cyanmethemoglobin (HiCN) method

This is the reference method for Hb determination in laboratories and for the calibration of hemoglobinometers. The principle is conversion of Hb to HiCN by the addition of potassium cyanide and ferricyanide whose absorbance is measured at 540 nm in a photoelectric calorimeter against a standard solution.50 The main cause of error in this method is sample dilution and presence of turbidity when measured at a single wavelength. As this method is time consuming, tedious and dependent on toxic cyanide reagents, it is no longer used in blood banks for Hb estimation.

Automated hematology analyzers

Automated hematology analyzers can provide high precision and enable high-sample throughputs but require regular maintenance, control of calibration, trained personnel and stable climatic conditions to operate them. A high cost of equipment and reagents is another constrain in developing countries. Hb determination is done by HiCN or the oxyhemoglobin method. In the former, the blood specimen is diluted with a reagent containing ferricyanide and cyanide, which converts Hb to HiCN. The absorbance of the HiCN at 540 nm wavelength is then used for quantitation. In the latter, the blood specimen is diluted with an aqueous solution tetrasodium salt of ethylenediaminetetraacetic acid (EDTA) and mixed with air to convert Hb to oxyhemoglobin. The absorbance of oxyhemoglobin at 540 nm is then measured. A typical analyzer working on venous blood has a CV of ≤1.2% for Hb measurement. Specific Gravity of Blood As a Screening Test For Blood Donors Essay

These analyzers have become increasingly sophisticated in the last few decades with the incorporation of noncyanide methods. Hb determination is done using sodium lauryl sulfate (SLS), a surfactant that dissolves lipoproteins of the cell membrane of the red blood cells to release Hb and converts it into SLS-Hb. Concentration of SLS-Hb is measured as light absorbance and is calculated by comparison with the absorbance of the diluent measured before the sample is added.52 This method is however not suitable for routine donor screening because of non-portability, high cost and especially the need to perform additional phlebotomy to obtain venous blood.

PHs

Point-of-care testing has suitably replaced traditional laboratory setup in the modern health care arena. PH provides easy and convenient Hb estimation based on spectrophotometric reading. In earlier generation devices (HemoCue 201 and HemoControl [EKF Diagnostics, GmbH, Barleben, Germany]), the blood drop is placed on a cuvette where sodium deoxycholate hemolyzes erythrocytes and Hb is released. Sodium nitrite converts Hb to met-Hb, which together with sodium azide gives azide-met-Hb. The absorbance is measured at two wavelengths (565 and 880 nm) in order to compensate for turbidity in the sample. They are standardized against the International Committee for Standardization in Hematology HiCN method, and the CV is 1.5%.53 Studies testing the accuracy and precision of these devices have found good agreement of the HemoCue PH to hematology analyzers with correlation as high as 99% in the hands of trained operators. Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Sources of error are incomplete filling, trapping of air bubbles and moisture. If a microcuvette contains the air bubbles in the optical eye (the portion through which the spectrophotometric measurement is taken), erroneously low readings could be produced. Readings must be taken within 10 minutes of filling the microcuvette, otherwise false results may also be obtained. The first drop of blood from finger prick should never be used in order to avoid the chances of hemolysis of blood cells coming in contact with alcohol on the prepared skin surface. High humidity has been shown to bias the function and Hb measurements by azide-met-Hb-based systems. Cuvettes should be stored in a carefully closed canister with desiccant and removed directly before usage. An Australian study has reported that cuvettes exposed to a high humidity for ≥4 days may underestimate Hb by as much as 2 g/dL by HemoCue  Specific Gravity of Blood As a Screening Test For Blood Donors Essay

These limitations have been mitigated in newer modified devices (Hemocue 301 [HemoCue AB] and DiaSpect Hemoglobin T [DiaSpect Medical GmbH, Sailauf, Germany]) using reagent-free cuvettes, which measure the absorbance of whole blood photometrically at the 506 nm isosbestic point – the wavelength in which the absorbance of the two main Hb derivatives, oxy-hemoglobin (HbO2) and deoxyhemoglobin, is the same and at 880 nm to compensate for turbidity. The reagent-free polystyrene cuvettes are not affected by the wide range of temperatures (10°C–40°C) and humidity and do not require special storage conditions. A study done in India to compare the performance of HemoCue 301 system at varied temperatures found that the device can function optimally even at temperatures >35°C and thus is suitable for use in outdoor blood donation camps in tropical counties.58 In addition, these cuvettes are cheaper and provide results more rapidly (<10 seconds).

Arrays of studies have been conducted to compare the performance of PH against various other methods of Hb estimation (Table 4). In most studies, Hb values are found to be increased by PH than the reference Hb values. In an effort to determine the source of this deviation, Bahadur et al24 compared the performance of HemoCue (model not specified) using capillary and venous blood. The capillary blood HemoCue values correlated neither with the cell counter values nor with the venous blood HemoCue values. On the other hand, there was a good correlation between venous HemoCue values and cell counter values, questioning the reliability of capillary blood. Gómez-Simón et al59 evaluated the performance of three PHs (HemoCue, STAT-Site MHgb and CompoLab HB system) and attributed the inaccuracy in their performance mainly to the use of capillary blood.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Table 4 Evaluation of performance of PH for blood donor Hb screening

Note: *Statistically significant difference between PH and the reference Hb value (p<0.05). Data presented as mean ± standard deviation.

Abbreviations: PH, portable hemoglobinometer; Hb, hemoglobin; hct, hematocrit; CV, coefficient of variation; NIS, noninvasive spectrophotometry; PPV, positive predictive value; NPV, negative predictive value; ICC, intraclass correlation coefficient.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

An Iranian study48 reported that as Hb increased above the cutoff level (12.5 g/dL), the discrepancy between the Hb levels measured with HemoCue 201+ (HemoCue AB) and the reference method also increased, and at levels >18 g/dL, there was no significant correlation between the two. At Hb levels <12.5 g/dL, there was a strong correlation between HemoCue 201+ and reference method measurements. The discriminating power for detecting anemia was greater for the capillary samples (79.5%) as compared to the VSs (64%).

A study by Morris et al55 evaluated the performance, reproducibility and accuracy of HemoCue 301+ (HemoCue AB, Angelholm, Sweden) for donor Hb measurement. The device is a modified version with cheaper reagent-free cuvettes, which are claimed to show no deterioration even in adverse climate. The authors reported an excellent linearity over a wide range of Hb levels (40–180 g/L) and a low level of imprecision (CV 0.4%–0.7%).

A Canadian study60 performed to assess the accuracy and precision of DiaSpect hemoglobin analyzer (DiaSpect Medical GmbH) in comparison to HemoCue 201 photometer found greater efficiency, improved ease of use and decreased deferrals. In terms of accuracy, correlation coefficients were similar between DiaSpect and reference methods (0.736) and between HemoCue and reference methods (0.856). In terms of precision, the CV ranged from 0.81% to 1.18% per sample for the HemoCue method and from 0.53% to 1.14% per sample for the DiaSpect method.

We had conducted a study21 at our center to evaluate the performance of DiaSpect Hemoglobin T and HemoControl PH. Neither of the two devices passed any donor with the Hb level <11 g/dL. Hb values measured in venous blood by HemoControl and DiaSpect were significantly higher than the corresponding values on the standard device, which may be due to differing testing principles of the devices and automated cell counter. DiaSpect and HemoControl showed CV of 2.2% and 2.5%, respectively.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Noninvasive spectrophotometry (NIS)

It has been introduced with the aim of preventing pain to blood donor, which deters most blood donors from donating blood. Other than avoiding venipuncture, this method also minimizes the risk of infection for health care workers, reduces the need for trained personnel, eliminates the generation of biohazardous waste, cuts down on consumables and is sampling error proof. The device automatically and continuously performs a self-test and calibration check during measurement sessions.

Presently, there are three technologies that use spectrophotometry for Hb measurement, differing in the type of sensor. One is occlusion spectroscopy (NBM 200; OrSense Co., Petah-Tikya, Israel), which is a portable device operative via a ring-shaped sensor, fitted on the donor’s finger. The pneumatic cuff applies pressure and temporarily stops the blood flow, creating an optical signal and yielding a high signal-to-noise ratio. Optical elements in multi-wavelength sensor perform a sensitive measurement of the light transmitted through the finger, in the wavelengths between 600 and 1500 nm. The differential light absorption, before and after blood flow obstruction in the finger, is used to determine the Hb level.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Another technology called pulse CO-oximetry (Pronto-7; Masimo Co, Irvine, CA, USA) places a multi-wavelength pulse CO-oximetry sensor over the individual’s fingertip, which acquires blood constituent data based on light absorption through a finger probe. Based on the light attenuation characteristics, the device calculates Hb. Adequate perfusion rate is required to measure Hb levels. Dark skin color and metallic nail polishes may interfere with the results. To obviate these biases, an optimization of the software and reconstruction of the sensor are recommended.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

The third technology is based on transcutaneous reflection spectroscopy (HemoSpect; MBR Optical Systems GmbH & Co. Wuppertal, Germany). It is a handheld device that uses a button sensor that adheres to the palm side of the finger of the nondominant hand. A sensor head placed on the skin projects a white light into the underlying tissue, via a waveguide. Some of the projected light is absorbed by the various components of tissue, while some of it is reflected back to the device. The spectrometer breaks the light down into its separate wavelengths, and an electronic evaluation unit connected to the system analyses the quantitative Hb value.

One study has compared all three NIS methods for Hb estimation of blood donors.28 Inappropriate donor referrals were 3.31% by HemoSpect, 5.83% by NBM 200 and 12.73% by Pronto-7. Based on lower susceptibility to failure, HemoSpect was approved by authors for donor screening at their blood center.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Several studies have been published comparing NIS point of care Hb estimation methods with standard practices in order to establish their accuracy, bias and precision (Table 5). Most studies have reported an overestimation of Hb measurements and have found lesser concordance with Hb values by the reference method as compared to PH.21,62,63

Table 5 Evaluation of performance of NIS for blood donor screening

Note: Data presented as mean ± standard deviation.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Abbreviations: ICC, intraclass correlation coefficient; NIS, noninvasive spectrophotometry; SD, standard deviation; Hb, hemoglobin; CV, coefficient of variation; PPV, positive predictive value; NPV, negative predictive value.

Baart et al64 studied the effect of skin color on differences between Hb measurements with the noninvasive test devices and the reference measurement. They found that darker skin color resulted in a smaller difference from reference for NBM 200 and HemoSpect. Similarly, smoking resulted on average in a 0.1 mmol/L smaller difference from reference values because of carboxyhemoglobin formation in smokers, which is measured with lower sensitivity by the noninvasive devices, leading to lower estimates of total Hb. The variation with oxygen saturation in blood donors has not been documented as the differences are too small to be discerned in normal healthy donors. Likewise, the frequency of hand or finger abnormalities in normal donors is too low to detect any potential effect.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Strategies and combination of techniques

Various studies have been done to establish alternatives to conventional Hb screening in an effort to reduce donor inconvenience and inappropriate deferrals. These include adoption of a combination of established techniques or varied algorithms.

Lotfi et al70 attempted to estimate blood donors’ eligibility while saving time and avoiding donors with acceptable Hb from being unnecessarily tested by finger prick. A venous blood sample was collected from donors at the end of their donation, and a post-donation Hb determination was performed with an automated hematology analyzer. Donors who qualified the criterion were permitted to donate after 6 weeks without any pre-donation Hb measurement. Donors with low post-donation Hb values were permitted to donate only after a pre-donation venous Hb determination. The sensitivity and specificity of this approach evaluated for >19,000 donors were 92.6% and 37.9%, respectively. It also saved 97% of donors from being tested unnecessarily by the capillary Hb measurement. This study was however criticized for phlebotomizing the donors at a very short interval.71 The predictive value of a previous Hb value will decrease obviously as the pre-donation interval will increase in routine settings.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Ziemann et al72 had also implemented a similar non-invasive strategy using historical Hb values, wherein pre-donation testing by venous blood was done only for donors with previous Hb values <12.9 g/dL for females or 13.9 g/dL for males. All others were allowed to donate without undergoing current Hb testing. A subsequent Hb testing for all donor candidates was done using blood in a diversion pouch of blood bag. They found this approach to be 95% accurate with a sensitivity of 57% and a specificity of 29%.

Pagliaro et al66 had used NBM 200 for Hb screening of all blood donors, and a hemocytometry test was added on a pre-donation VS drawn from donors who, though fit to donate, had critical Hb values in their previous record. The authors found this approach to improve donor selection efficiency and reduce inappropriate donations, particularly by female donors.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Future directions

A method to qualify as quintessential for blood donor screening should be valid, quick, easy to perform, donor friendly, cost effective, portable, reagent free, pre-analytical error proof and operable by all. None of the currently available devices for Hb screening offer such a miraculous package. Sneak peek into the emerging techniques provides some hope for the future. A number of smartphone applications have been developed that can estimate the Hb level noninvasively using smartphone camera and a light source. Hb measurement is done by chromatic analysis of the blood at the fingertip by measuring the absorption properties of the blood at different wavelengths of light. The ubiquity of smartphone makes this technique easily deployable. Besides, substantial amount of research is being done to refine optical and imaging-based sensing for evaluating Hb levels, which offer a great promise in time to come.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

To conclude, in addition to numerical cutoff values, adequate attention should be focused on the selection of methodology and guidelines should be set so as to define the minimum standards of its optimum functioning. A standard protocol should be in place for each blood collection center to check the quality of results produced in the form of minimum acceptable performance characteristics. For obtaining optimum results using any validated technique, it is of foremost importance to avoid pre-analytical errors in the first place. For e.g., if using finger-stick blood sample, squeezing should be avoided; first, drop of blood should be wiped off and operator should be well trained in the use of lancet so as to penetrate a uniform depth. Since all the prevailing techniques in recent times are sufficiently convenient and accurate, greater emphasis should be focused on their robustness in day-to-day operations, competency of the staff in obtaining reliable outcomes, regular proficiency testing of the results, meticulous documentation and maintenance of data base. The technical personnel operating the device should be adequately trained in terms of test requirements, performance, limitations and potential interferences. Proficiency testing should be established for continuous monitoring of the quality of results with internal quality controls and external quality assessment.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Each blood centre should develop its own algorithm for donor screening based on donors population characteristics (ethnicity, proportion of female donors, repeat donation frequency etc), and economic feasibility. Looking at the ergonomics, noninvasive devices may seem to be a lucrative option both for donors and health care providers. However, implementing them as the sole method for donor screening at present may prove somewhat precarious. They may be implemented for primary screening of repeat donors after reviewing blood donors’ previous Hb level. If the previous or presently tested Hb level falls near borderline, it should be repeated on a more sensitive invasive device. For all first-time donors, Hb screening should be done on a validated point-of-care invasive device.

There are a few limitations of this review. One is that some of the cited publications lack a suitable statistical method for comparing these techniques. Second, in a few publications, model of equipment (especially HemoCue) has not been specified. Moreover, cutoff Hb guidelines and hence interpretation of results vary with the geographic location of the center where the study is carried out.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

When it is first suspected that an infectious agent may be transmitted by transfusion, the initial response is to develop donor deferral policies using epidemiologic data [3,5]. After this initial step, subsequent review and debate often leads to the nationwide implementation of a particular donor screening procedure following recommendations of the US Food and Drug Administration (FDA) and/or the AABB (formerly the American Association of Blood Banks) [7,8]. Once implemented, screening procedures tend to become permanent due to the current regulatory, political, and legal climate, even if their efficacy cannot be established.
For transfusion-transmitted diseases such as variant Creutzfeldt-Jacob disease (CJD) and malaria, non-laboratory donor screening procedures are the only method available for increasing transfusion safety [9-12]. By contrast, for infectious diseases for which routine blood donor testing is performed (eg, HIV, hepatitis B and C viruses, and others), the importance of non-laboratory donor screening procedures relates to their ability to identify some potentially infectious donors during the infectious window period that precedes the development of a positive laboratory test Specific Gravity of Blood As a Screening Test For Blood Donors Essay

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The haemoglobin (Hb) concentration should be determined each time a potential donor presents. The acceptable lower limits for venous blood are 125 g/L for female donors and 135 g/L for male donors (140 g/L for all donors of double red cells by apheresis).

Several methods of screening donors for their blood Hb concentration are available (or in development). These include:

gravimetric method using solutions of copper sulphate on blood samples obtained by fingerprick

spectrophotometric devices using capillary or venous samples

non-invasive technology

full blood count using venous or capillary samples.
The final method chosen must be validated, and validation should include comparison to a full blood count measured on a venous sample.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

A donor whose fingerprick sample fails the Hb screening should be offered a test on a sample of venous blood for accurate determination of their Hb concentration. This is to enable the donor to receive appropriate advice either from the donor clinical support officer or the donor’s general practitioner. The Hb concentration in the venous sample may be determined immediately at the session if a suitably validated haemoglobinometric device capable of rapid and accurate analysis is available. If the concentration so determined is at or exceeds those quoted above the donor may be invited to give a full donation.

Donors whose Hb concentration is below the minimum values should not be bled. The reason for deferral should be explained and the donors advised to see their own general practitioner if this is considered to be appropriate as defined by Blood Service procedures.

If a quantitative method of Hb determination is employed, before or after the donation, individuals found to have a concentration of Hb above the normal upper limit as indicated in the JPAC Donor Selection Guidelines1 should be referred for further investigations.

3.15.2: Copper sulphate haemoglobin screen
If used, aqueous copper sulphate, coloured blue, with a specific gravity of 1.053, equivalent to 125 g/L haemoglobin, is required to test female donors. If used, aqueous copper sulphate, coloured green, with a specific gravity of 1.055, equivalent to 135 g/L, is required to test male donors. These stock solutions should be colour-coded and labelled accordingly.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

Stock solutions shall be stored at room temperature in tightly capped, dark glass containers to prevent evaporation and contamination. Copper sulphate solutions are temperature sensitive and must be stored and used within the temperature ranges specified in the Blood Service’s procedures.

3.15.3: Additional tests for component donors
In addition, component donors should have the following blood tests performed at the initial visit:

full blood count for all donors

serum albumin and total serum protein levels for plasma donors (total serum protein has no relevance to platelet donors).
The lower limit of acceptability for haemoglobin level should be as for normal whole blood donation. Special considerations as stated in sections 3.6.3, 3.14.1 and 3.15.1 apply to red cell donation by apheresis.

The platelet count should be performed at each visit for plateletpheresis donors.

The full blood count must be carried out at least annually for all component donors and serum albumin and total serum proteins must be measured at least annually for plasma donors. A system must be in operation for regular review of these results, together with a documented protocol of the action to be taken in the light of any abnormal findings.Specific Gravity of Blood As a Screening Test For Blood Donors Essay

All Blood Services should perform a risk assessment to evaluate the relative risks and benefits of implementation of leucocyte antibody screening of female platelet donors. If leucocyte antibody screening is implemented, female platelet donors with a subsequent history of pregnancy (regardless of the outcome) should be re-tested (see section 16.8.8).

Blood transfusion services (BTS) have the responsibility to collect blood only
from donors who are at low risk for any infection that could be transmitted
through transfusion and who are unlikely to jeopardize their own health by blood
donation. A rigorous process to assess the suitability of prospective donors is
therefore essential to protect the safety and sufficiency of the blood supply, and
safeguard the health of recipients of transfusion and blood donors themselves,
while ensuring that suitable donors are not deferred unnecessarily.
These World Health Organization (WHO) guidelines, Blood donor selection: guidelines
on assessing donor suitability for blood donation have been developed to assist
blood transfusion services in countries that are establishing or strengthening
national systems for the selection of blood donors1. They are designed for use
by policy makers in national blood programmes in ministries of health, national
advisory bodies such as national blood commissions or councils, and blood
transfusion services.Specific Gravity of Blood As a Screening Test For Blood Donors Essay
WHO guidance on criteria for the selection of blood donors was first published in
the distance learning materials, Safe Blood and Blood Products, Module 1: Safe
Blood Donation (1) in 1994. These earlier recommendations were developed on
the basis of international best practice but did not have a clear evidence base.
In 2009, the WHO Blood Transfusion Safety programme (WHO/BTS) convened a
guideline development group (GDG) to prepare evidence-based recommendations
on criteria for assessing the suitability of blood donors. The GDG also recognized
the need to provide guidance on establishing national systems for blood donor
selection. Details of the members of the GDG and their areas of expertise are
provided in the Acknowledgements.
WHO/BTS also established an external review group (ERG) to review and comment
on the draft guidelines at various stages of the developmental process. The ERG
comprised members of the WHO Expert Advisory Panel on Blood Transfusion
Medicine and experts from WHO Collaborating Centres in Transfusion Medicine
as well as directors of national blood transfusion services and blood programme
managers from each WHO region (see Acknowledgements). The role of the ERG
was to review the draft guidelines and advise WHO on the relevance, applicability
and feasibility of the recommendations. An advanced draft was reviewed by
participants and facilitators during an inter-regional workshop on blood donor
selection and donor counselling for priority countries in the African and Eastern
Mediterranean regions, June 2011, Nairobi, Kenya.
The guidelines are presented in two parts. Part 1 (Sections 2 and 3) addresses
the requirements for an effective national system for blood donor selection; policy
recommendations are provided on p. 5. Part 2 provides guidance on specific
criteria for blood donor selection in relation to general donor assessment, donor  Specific Gravity of Blood As a Screening Test For Blood Donors Essay

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