TABLE 7.
Potentially interfering substance, microorganism pool, or drug poola | Specificityb (%) | Sensitivityc |
---|---|---|
Endogenous substances (level tested) | ||
Hemoglobin (500 mg/dl) | 98.0 | 100 |
Conjugated bilirubin (60 mg/dl) | 98.0 | 98.0 |
Unconjugated bilirubin (60 mg/dl) | 100 | 96.0 |
Triglycerides (3,000 mg/dl) | 100 | 98.0 |
Human immunoglobulin (8 g/dl)d | 100 | 100e |
Microorganisms and viruses | ||
Pool 1 | 98.0 | 96.0 |
Pool 2 | 100 | 100 |
Pool 3 | 100 | 100 |
Pool 4 | 100 | 100 |
Pool 5 | 100 | 100 |
Commonly prescribed drugs | ||
Pool 1 | 100 | 98.0 |
Pool 2 | 100 | 100 |
Pool 3 | 100 | 98.0 |
Pool 4 | 100 | 100 |
Pool 5 | 100 | 100 |
Pool 6 | 100 | 100 |
For the microorganisms pools, the testing was done at 50,000 CFU/ml or 50,000 copies/ml. The microorganism pools included the following: pool 1, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Haemophilus influenzae, and cytomegolovirus; pool 2, Enterobacter cloaceae, Pseudomonas fluorescens, Staphylococcus aureus, Serratia marcescens, and Streptococcus pneumoniae; pool 3, Staphylococcus epidermis, Streptococcus group B, Candida albicans, HIV-1 subtype B, and hepatitis B virus; pool 4, HIV-1 subtypes A, C, and D; and pool 5, HIV-1 subtypes E and F and group O, and Propionibacterium acnes. The drug pools included the following: pool 1, alpha interferon 2b, ribavarin, and azathioprine; pool 2, cyclosporine, spironolactone, and prednisone; pool 3, alpha interferon 2b, tacrolimus, and amantidine HCl; pool 4, fluoxetine HCl, Peginterferon Alfa-2b, and azidothymidine; pool 5, ganciclovir and dideoxycytidine; and pool 6, didanosine and dedehydreoxythymidine.
Specificity defined as the percentage of nonreactive samples of total samples tested. A total of 50 samples were tested for each endogenous substance and disease-causing organism pool. A total of 50 samples were tested for each of drug pools 1 and 3, 60 samples were tested for drug pool 2, and 40 samples were tested for drug pools 4 to 6.
Sensitivity defined as the percentage of reactive samples of a total of 50 samples tested.
Normal human serum contains 4 to 8 g of immunoglobulin per dl. With an additional 8 g/dl added, this would bring the total concentration to 12 to 16 g of immunoglobulin per dl.
Only 49 samples tested.