Studies comparing the polyspecific ELISA and IgG-specific ELISA in the diagnosis of heparin-induced thrombocytopenia (HIT).
| . | . | . | Polyspecific ELISA . | IgG-specific ELISA . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ref . | Study population (n) . | Definition of HIT . | Assay . | TP . | TN . | FP . | FN . | Assay . | TP . | TN . | FP . | FN . |
| *Clinical probability estimated using the 4T’s scoring system. | ||||||||||||
| †Genetics Testing Institute (Waukesha, WI, USA) | ||||||||||||
| ‡Patients with an indeterminate HIPA result in the original study were excluded from the current analysis | ||||||||||||
| §Patients with a negative polyspecific ELISA were not tested with the IgG-specific ELISA and are assumed to be negative with respect to this assay for the current analysis | ||||||||||||
| ¶Fall of ≥ 50% in platelet count beginning on day ≥ 5 of heparin therapy without other apparent cause and platelet count recovery upon cessation of heparin | ||||||||||||
| TP indicates true positive; TN, true negative; FP, false positive; FN, false negative; HIPA, heparin-induced platelet activation assay; and SRA, carbon-14 labeled serotonin release assay. | ||||||||||||
| 6 | Patients with suspected HIT (500) | Positive HIPA and intermediate to high clinical pre-test probability* | GTI† | 35 | 376 | 89 | 0 | In-house | 35 | 414 | 51 | 0 |
| 7 | Patients with suspected HIT (100) | Positive SRA and intermediate to high clinical pre-test probability* | GTI† | 16 | 68 | 16 | 0 | In-house | 16 | 69 | 15 | 0 |
| 8 | Patients with suspected HIT (1582)‡ | Positive HIPA | In-house | 95 | 1386 | 100 | 1 | In-house | 92 | 1412§ | 76 | 2§ |
| 9 | Patients with suspected HIT (736)‡ | Positive HIPA | In-house | 50 | 632 | 51 | 3 | In-house | 46 | 655§ | 28 | 7§ |
| 10 | Patients receiving thromboprophylaxis after total hip arthroplasty (448) | Clinical | GTI† | 14 | 357 | 77 | 0 | In-house | 14 | 393 | 36 | 0 |
| Pooled total 3366 | 210 | 2819 | 333 | 4 | 203 | 2943 | 206 | 9 | ||||
| . | . | . | Polyspecific ELISA . | IgG-specific ELISA . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ref . | Study population (n) . | Definition of HIT . | Assay . | TP . | TN . | FP . | FN . | Assay . | TP . | TN . | FP . | FN . |
| *Clinical probability estimated using the 4T’s scoring system. | ||||||||||||
| †Genetics Testing Institute (Waukesha, WI, USA) | ||||||||||||
| ‡Patients with an indeterminate HIPA result in the original study were excluded from the current analysis | ||||||||||||
| §Patients with a negative polyspecific ELISA were not tested with the IgG-specific ELISA and are assumed to be negative with respect to this assay for the current analysis | ||||||||||||
| ¶Fall of ≥ 50% in platelet count beginning on day ≥ 5 of heparin therapy without other apparent cause and platelet count recovery upon cessation of heparin | ||||||||||||
| TP indicates true positive; TN, true negative; FP, false positive; FN, false negative; HIPA, heparin-induced platelet activation assay; and SRA, carbon-14 labeled serotonin release assay. | ||||||||||||
| 6 | Patients with suspected HIT (500) | Positive HIPA and intermediate to high clinical pre-test probability* | GTI† | 35 | 376 | 89 | 0 | In-house | 35 | 414 | 51 | 0 |
| 7 | Patients with suspected HIT (100) | Positive SRA and intermediate to high clinical pre-test probability* | GTI† | 16 | 68 | 16 | 0 | In-house | 16 | 69 | 15 | 0 |
| 8 | Patients with suspected HIT (1582)‡ | Positive HIPA | In-house | 95 | 1386 | 100 | 1 | In-house | 92 | 1412§ | 76 | 2§ |
| 9 | Patients with suspected HIT (736)‡ | Positive HIPA | In-house | 50 | 632 | 51 | 3 | In-house | 46 | 655§ | 28 | 7§ |
| 10 | Patients receiving thromboprophylaxis after total hip arthroplasty (448) | Clinical | GTI† | 14 | 357 | 77 | 0 | In-house | 14 | 393 | 36 | 0 |
| Pooled total 3366 | 210 | 2819 | 333 | 4 | 203 | 2943 | 206 | 9 | ||||