Introduction
Acid phosphatase is an enzyme that catalyzes the hydrolysis of phosphate esters in an acidic environment. This chemical reaction is crucial for various metabolic processes. Therefore, acid phosphatase exists in several biological kingdoms, including plants, animals, fungi, and bacteria. Research has shown that acid phosphatase plays a crucial role in various physiological processes in humans, including bone resorption, immune defense, pathogen clearance, epithelial growth regulation, and iron transport.[1]
Pathophysiology
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Pathophysiology
The acid phosphatase family is generally divided into 2 major groups based on the presence or absence of a binuclear metal center. The first group, known as metallohydrolases, exhibits a characteristic purple color due to a charge transfer between a tyrosine residue and Fe(III) at the active site. These enzymes are known as purple acid phosphatases. These enzymes are also referred to as tartrate-resistant acid phosphatases because they are not inhibited by tartrate. This resistance is utilized in biochemical assays to distinguish it from other types of acid phosphatase.[2][3][4][5]
Clinical Significance
Acid Phosphatase as a Marker
Acid phosphatase is typically found in blood at levels of ≤2 ng/mL. Because it is secreted by various tissues, it serves as a nonspecific marker and is more valuable in monitoring the response to therapy and prognosis than in diagnosis. Prostate cancer is one of the most common cancers in men worldwide. A specific form of acid phosphatase, which is sensitive to tartrate inhibition and known as secretory prostatic acid phosphatase, is normally secreted by prostate tissue. However, cancerous prostate tissue tends to overexpress it. Most patients with prostate cancer have high levels of acid phosphatase, especially if the cancer has metastasized to bones. Therefore, it was once the major serum marker for prostate cancer screening and staging but has recently been replaced by the more specific and sensitive prostate-specific antigen, as emphasized by the American Urological Association and the Society of Urologic Oncology in their most recent guidelines.[6][7][8]
Recent studies showed that elevated prostatic acid phosphatase in patients with prostatic cancer is associated with higher tumor grade, increased risk of invasion and metastasis, and poorer survival outcomes in prostate cancer patients. Therefore, it is used for prognostic assessment and monitoring disease progression rather than for initial diagnosis or screening.[9] Additionally, prostatic acid phosphatase has applications in forensic science, as it is actively released into seminal fluid and can be used to identify it in law enforcement investigations.[10][11]
Bone tissue is a dynamic structure that is continuously formed and resorbed in a balanced process. Osteoclasts, the cells responsible for bone resorption, express another acid phosphatase isoform. Acid phosphatase plays a direct role in bone resorption and serves as a reliable marker of osteoclast number and activity. Bone acid phosphatase is distinct from prostatic acid phosphatase because it is resistant to tartrate, making it a tartrate-resistant acid phosphatase. Indeed, several studies have shown that acid phosphatase levels increase with age, especially in postmenopausal women, and correlate with other bone turnover markers and bone mineral density, supporting its clinical significance in assessing bone resorption and the risk of osteoporosis.[12][13] In osteoporosis—the most common bone disease in humans—the normal balance between bone formation and resorption becomes disrupted, resulting in increased bone resorption. Several serum markers for bone resorption have been proposed. The American Association of Clinical Endocrinology recommends using serum C-terminal telopeptide to monitor bone resorption and procollagen type I N-terminal propeptide to monitor bone formation during osteoporosis treatment. Although acid phosphatase is a useful marker for monitoring osteoporosis due to its resistance to hemolysis and minimal day-to-day variability, it is not yet the preferred standard for routine clinical use. C-terminal telopeptide and procollagen type I N-terminal propeptide remain the primary markers according to current guidelines from the American Association of Clinical Endocrinology.[12][14][15]
Acid phosphatase has also been studied in relation to various malignancies. Hairy cell leukemia is a chronic lymphoproliferative disease characterized by the infiltration of the bone marrow, spleen, and blood by neoplastic B cells, resulting in splenomegaly, anemia, and recurrent infections. Leukemic cells in hairy cell leukemia have an intracytoplasmic tartrate-resistant acid phosphatase enzyme. In most patients, aspirates from blood or bone marrow are testable for the presence of tartrate-resistant acid phosphatase, which serves as a highly sensitive and specific marker for hairy cell leukemia, aiding in its detection and diagnosis.[16] Furthermore, when metastasizing to bones, several types of malignancies can induce bone resorption through several steps, including higher expression of acid phosphatase. In these cases, acid phosphatase serves as a serological and histological prognostic marker and a tool to monitor treatment response.[17][18] Another clinical entity where acid phosphatase can be useful is Gaucher disease, the most common lysosomal storage disease observed worldwide. Gaucher disease commonly presents with unexplained hepatosplenomegaly and pancytopenia. The disease is treatable through enzyme replacement therapy with glucocerebrosidase. A serum maker known as chitotriosidase is typically used to monitor the disease burden and response to enzyme replacement. However, tartrate-resistant acid phosphatases may be used instead as a marker when it is normal.[19]
Acid Phosphatase as a Therapeutic Target
As noted above, acid phosphatase has largely been replaced as a marker by more sensitive and specific markers. However, in the past decade, it has gained more interest as a target for immunotherapy against cancers, particularly prostate cancer. A novel strategy using immunopeptidomic profiling has identified multiple HLA-A*02:01-restricted prostatic acid phosphatase peptides that can be recognized by T-cell receptors, supporting the feasibility of developing T-cell–based immunotherapies targeting prostatic acid phosphatase-expressing tumor cells in prostate cancer.[20] These antigens can be tumor-specific, exclusively expressed on cancerous cells, or nonspecific antigens expressed on both normal and cancerous cells; however, they are much more highly expressed on cancerous cells, such as prostatic acid phosphatase.[21]
Sipuleucel-T is an autologous cellular immunotherapy composed of autologous peripheral blood mononuclear cells, including antigen-presenting cells, activated ex vivo with a recombinant fusion protein of prostatic acid phosphatase linked to granulocyte-macrophage colony-stimulating factor. The process involves extracting the patient's autologous dendritic cells by leukapheresis, which are then loaded with Sipuleucel-T ex vivo and re-infused into the patient. The dendritic cells stimulate T cells to target cells expressing prostatic acid phosphatase.[22]
The pivotal Phase 3 placebo-controlled clinical trials demonstrated a statistically significant improvement in median overall survival for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer treated with sipuleucel-T compared to placebo (25.8 months versus 21.7 months; hazard ratio, 0.78; 95% CI, 0.61 to 0.98; P = 0.03). The administration of sipuleucel-T every 2 weeks for a total of 3 doses has been approved by the Food and Drug Administration to treat metastatic castration-resistant prostate cancer in patients with metastatic castration-resistant prostate cancer who are asymptomatic or minimally symptomatic, those who have no visceral metastases, and those who have not received both docetaxel and a novel hormone therapy.[22] Moreover, several clinical trials are currently underway to evaluate the efficacy of sipuleucel-T in earlier stages of prostate cancer and its efficacy when combined with different other chemotherapeutic agents. Other immunotherapeutic strategies targeting prostatic acid phosphatase are also being developed, such as plasmid DNA vaccines encoding prostatic acid phosphatase. Carriers transport these DNA vaccines to their destination in vivo, where the antigen-presenting cells can induce an immune response. Johnson and his colleagues developed a DNA vaccine for acid phosphatase using attenuated Listeria monocytogenes as a carrier, which selectively infects antigen-presenting cells. Two Phase 1 clinical trials and preclinical studies on rodent models have yielded promising results, and a randomized, placebo-controlled Phase 2 clinical trial is currently underway to evaluate this vaccine.[23]
Quality Control and Lab Safety
For effective statistical quality control (QC) in quantitative measurement procedures such as acid phosphatase testing, it is recommended to use at least 2 different concentrations of QC materials that span clinically relevant decision levels and cover the full analytical measuring interval of the test system.[24] In cases with multiple medical decision points, more than 2 QC levels may be required for comprehensive monitoring.[25]
Under Clinical Laboratory Improvement Amendments (CLIA) regulations, laboratories must perform a minimum of 2 levels of QC per 24 h for each quantitative test. However, based on risk assessment and testing frequency, some laboratories may implement more frequent QC, such as on a per-run or per-batch basis.[26] CLIA also promotes the implementation of an individualized QC plan, which includes risk assessment, a tailored QC strategy, and continuous quality assurance monitoring.[27] The CLSI EP23 guideline provides a framework for developing such risk-based QC procedures, focusing on minimizing patient harm and validating that controls are effective. Laboratory directors are ultimately responsible for determining whether sufficient system and procedural safeguards are in place to ensure that test results are reliable at the time of reporting.[28]
In continuous measurement systems, event-based QC is required. QC samples should be tested before and after scheduled events such as recalibration or instrument maintenance that may impact measurement performance. These actions are intended to restore optimal system function and correct for calibration drift or component wear. If QC is not run around these events, laboratories may miss the detection of performance shifts. Testing QC samples after these interventions confirms that procedures were properly carried out and that testing can safely resume.[29][30]
The application of Westgard rules supports the detection of both systematic and random errors, enabling timely corrective actions.[31] In addition, ISO 15189 emphasizes the importance of using third-party QC materials alongside manufacturer-provided controls to enhance the objectivity and robustness of QC practices.[32]
QC materials—particularly lyophilized controls—must be reconstituted precisely according to the manufacturer's instructions.[33] In acid phosphatase testing, where enzyme stability is critical, proper handling, stabilization, and storage conditions must be observed. When QC values fall outside established ranges, laboratories should verify instrument calibration, reagent integrity, and analytical technique. If issues persist, the test should be repeated with a freshly prepared control. Continued discrepancies may require the use of a new calibrator or reagent, and unresolved problems should be escalated to technical support.[34][25] Each laboratory is responsible for defining control limits and corrective action protocols tailored to test performance characteristics and clinical relevance. Calibration should be conducted with every new reagent batch, following equipment maintenance, or when QC results deviate without an identifiable cause.[35] All QC results, corrective actions, and calibrations must be documented in accordance with audit and accreditation requirements.[36] Participation in an external quality assessment program is crucial for evaluating performance against peer laboratories. External quality assessment outcomes should be carefully reviewed, with root cause analysis conducted for any discrepancies. Additionally, it is equally important to assess the potential clinical impact on patient results, whether the failure originates from individualized quality control or external quality assessment issues.[37][38]
Laboratory safety is fundamental to the reliable and sustained performance of clinical chemistry procedures, such as acid phosphatase testing. These tests often involve the handling of blood and serum specimens, requiring strict adherence to biosafety protocols. The consistent use of personal protective equipment, including gloves, lab coats, and face shields, is essential to reduce exposure risk. Hand hygiene must be rigorously maintained to prevent cross-contamination. Given the possibility of exposure to bloodborne pathogens such as hepatitis B, hepatitis C, and HIV, laboratory personnel must be appropriately trained and vaccinated, especially against hepatitis B. A strong safety culture, supported by regular audits, training sessions, protocol compliance, proper biohazard waste disposal, and effective spill management, is crucial for ensuring the protection of personnel and the integrity of test results.[39][40]
Enhancing Healthcare Team Outcomes
Treatment with sipuleucel-T requires coordination from a multidisciplinary team, including an oncologist, a pharmacist, infusion room nurses, and clinic nurses. The process begins with leukapheresis, where the patient's blood is collected. The blood sample is then sent to the manufacturing facility, where the harvested antigen-presenting cells are incubated with recombinant prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor, thereby activating the antigen-presenting cells. The activated antigen-presenting cells are then packed and returned to the infusion center, where they are infused into the patient. The approved treatment regimen involves biweekly infusions.
The cost of sipuleucel-T is approximately $100,000 per month, making it one of the most expensive cancer treatments on the market. Although sipuleucel-T has shown superior efficacy to docetaxel, the cost difference may barely compensate for the added median life; therefore, funding becomes an obstacle. Fortunately, the Centers for Medicare and Medicaid cover sipuleucel-T treatments. Nonetheless, involving financial personnel and social workers in the treatment process may facilitate funding. In addition, exploring equally effective yet less expensive options is certainly warranted to decrease the economic burden on society.[41][42]
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