Table 4.
Evaluation of performance of PH for blood donor Hb screening
| S. No. | Author | Reference method (automated hematology analyzer) | PH | Bias | Accuracy | Performance characteristics | Precision | Inference |
|---|---|---|---|---|---|---|---|---|
| 1 | Tondon et al36 | ABX Micros 60 | HemoCue | +0.24 g/dL | 97% | Sensitivity 99.4%, specificity 84.4%, PPV 97% and NPV 96.6% | – | Bias nonsignificant. Recommended for subsequent testing of inappropriate deferrals by CuSO4 |
| 2 | Mendrone et al23 | ABX Pentra 60 | HemoCue 201 | +0.77 g/dL | 89.3% | Sensitivity 56% and specificity 93.5% | – | HemoCue 201+ showed greater discriminating power for detecting anemia in prospective blood donors than the micro-hct method |
| 3 | Sawant et al61 | Beckman Coulter Counter | HemoCue | +1.5 g/dL | – | Sensitivity 99%, specificity 45%, PPV 43% and NPV 99% | – | Concordance correlation coefficient between HemoCue and the reference method (0.74) |
| 4 | Gómez-Simón et al59 | Coulter MAXM | HemoCue | +0.78±0.73 g/dL* | 82% ICC 0.78 |
CV 2.28±0.73% | HemoCue showed the best agreement with venous Hb determination | |
| STAT-Site M Hgb | +0.51±0.96 g/dL* | 76% ICC 0.75 |
– | CV 4.79±1.74% | ||||
| CompoLab Hb | No significant difference | 85% ICC 0.69 |
– | CV 3.74±2.21% | ||||
| 5 | Rudolf-Oliveira et al20 | Sysmex XE-2100D | HemoCue | +0.72 g/dL | ICC 0.763 | – | – | Repeat on automated hematology analyzer with venous blood when capillary Hb level is near borderline |
| 6 | Patel et al10 | Cell-Dyn 4000 | HemoCue 201 | +0.69 g/dL* (capillary blood) and +0.38 g/dL* (venous blood) | 90.6% | – | Mean absolute difference in duplicate tests of 0.76 (relative error 5.6%) | Hb with HemoCue consistently higher than the reference method |
| 7 | Kim et al62 | Beckman Coulter LH500 | HemoCue | +0.3 g/dL | ICC 0.86 | Sensitivity 42.7% and specificity 98.6% | – | Hb measurements by HemoCue showed excellent agreement with the automated hematology analyzer |
| 8 | Belardinelli et al63 | Beckman Coulter | HemoCue | +0.83±0.70 g/dL | 92% | Sensitivity 99% and specificity 99.5% | – | Higher accuracy than NIS devices |
| 9 | Shahshahani and Amiri48 | Roche ABX Cobas Micros | HemoCue 201 | +0.79 g/dL* | For Hb<12.5 g/dL, 97.5% | For Hb<12.5 g/dL, sensitivity 79.5%, specificity 100%, PPV 100% and NPV 97.2% | – | Qualitative methods to be used for primary screening, and accurate quantitative methods to be used in clinically suspicious cases or when qualitative methods fail |
| 10 | Singh et al21 | Sysmex KX-21 | DiaSpect | −0.18 g/dL* | For Hb>18 g/dL, 81.5% | For Hb>18 g/dL, sensitivity 100%, specificity 79.8%, PPV 31.7% and NPV 100% | ||
| HemoControl | −0.22 g/dL* | ICC 0.78 | Sensitivity 98.1%, specificity 78.4%, PPV 35.9% and NPV 99.7% | CV 2.19% | DiaSpect more accurate and rapid, therefore apt for donor screening | |||
| 11 | Baart et al64 | XT-188i, Sysmex | HemoCue 201 | Males* +0.24±0.42 mmol/L | ICC 0.77 | Sensitivity 86.8%, specificity 94.7%, PPV 66.9% and NPV 98.3% | CV 2.51% | |
| Females* +0.18±0.41 mmol/L | 94.1% | Sensitivity 30.1%, specificity 99.8%, PPV 94.4% and NPV 94.1% | – | Measurements with invasive devices showed strong correlation and better agreement with venous values | ||||
| HemoCue 301 | Males* +0.35±0.44 mmol/L | 90% | Sensitivity 36.6%, specificity 98.9%, PPV 84.2% and NPV 90.3% | |||||
| Females* +0.33±0.44 mmol/L | 93.7% | Sensitivity 27.9%, specificity 99.4%, PPV 79.2% and NPV 94.1% | ||||||
| 12 | Sümnig et al65 | Siemens Advia 2120i | HemoCue 301 | +0.43 g/dL* | 87.7% | Sensitivity 27.9%, specificity 97.7%, PPV 67.4% and NPV 89% | ||
| 13 | Pagliaro et al66 | Beckman Coulter | HemoControl | – | 97.6% | Sensitivity 23.1%, specificity 99.2%, PPV 78.9% and NPV 90.6% | CV 3.23% | May be used as the second-line method to noninvasive devices in cases where retesting is required |
| 14 | Ardin et al28 | Sysmex KX 21n | CompoLab Hb | −0.53±0.81 g/dL | – | Males: sensitivity 13.22%, specificity 99.89%, PPV 88.46% and NPV 94.58% Females: sensitivity 32.14%, specificity 99.76%, PPV 96.92% and NPV 86.40% |
– | Measuring Hb alone on PH not satisfactory |
| 92% | – | – | 4.48% prospective blood donors would falsely be deferred in using CompoLab Hb |
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.