Tests: Sweden checks less at diagnosis and more before treatment¶
The Swedish guideline separates a lean baseline at diagnosis from a fuller assessment before treatment. At diagnosis it is leaner than iwCLL in three ways (VP8.2 §8.1–8.2; VP8.2 §2.3) [E]:
- no routine β2-microglobulin (removed in version 8.0, 2024);
- no baseline CT;
- no hepatitis or HIV serology until treatment is considered.
Staging uses palpation and blood counts only. Nodes found only on ultrasound or CT do not count. Cytopenias count only if marrow failure causes them; autoimmune cytopenias do not (VP8.2 §8.4.1; iwCLL 2018).
[I] If the diagnosis was made on excised lymph nodes, ask how they and any remaining palpable nodes were counted. Nobody can work out the stage from the fact that nodes were involved.
| Staging | Definition (iwCLL/VP8.2) |
|---|---|
| Binet A | Hb ≥100 g/L, platelets ≥100×10⁹/L, fewer than 3 involved areas. The five areas are head-neck, axillae, groins, palpable spleen and palpable liver; a node counts at ≥1 cm |
| Binet B | Same blood counts, 3 or more areas |
| Binet C | Hb <100 g/L and/or platelets <100×10⁹/L, caused by marrow failure |
| Modified Rai | Low (0), intermediate (I–II), high (III–IV) risk; uses an anaemia threshold of 110 g/L (EHA 2026, Table 3) |
Tiers in the table: A = routinely appropriate at diagnosis; B = mainly needed before treatment; C = only in selected circumstances.
| Test | Tier | Swedish VP8.2 | International position | Comment |
|---|---|---|---|---|
| History: B symptoms, infections, autoimmune disease, other cancers, family history, cardiovascular disease, medications | A | §8.1 | iwCLL, EHA and S3 agree | Bring a written list of medicines and supplements |
| Examination: nodes measured in two dimensions; liver and spleen in cm below the rib margin; performance status | A | §8.1 | iwCLL records the largest cervical, axillary and inguinal nodes | Basis for Binet/Rai |
| Blood count: Hb, white cells, differential, platelets, reticulocytes | A | §8.1 | iwCLL "Always"; prolymphocyte % "desirable" | Needed for staging and treatment criteria |
| Blood flow cytometry: clonal B-cell count and light-chain restriction | A | §7.1 | iwCLL "Always" | Decides CLL vs SLL |
| Creatinine, urate, liver tests (ASAT, ALAT, albumin, bilirubin, ALP), LD | A | §8.1 | iwCLL also lists haptoglobin and β2M | LD is also a Richter warning marker |
| Serum protein electrophoresis (elfores) | A | §8.1 | iwCLL and EHA: quantitative IgG, IgA, IgM | [I] Ask for quantitative IgG, IgA and IgM as well: infection risk and immunoglobulin-replacement decisions use them |
| Direct antiglobulin test (DAT) | A | §8.1 | iwCLL: before treatment | Screens for autoimmune haemolysis |
| Vaccination review | A | §16.3 | EHA level III, grade B | Section 12 |
| FISH: del(11q), del(13q), +12, del(17p) | B | §8.2; repeat before each new treatment line if it affects the choice | iwCLL "Always" before treatment; German S3 "kann" (may) at diagnosis; EHA: not needed in asymptomatic early stage | Done in Lund, about 7 days |
| TP53 sequencing (if FISH shows no del(17p)); same sample as FISH | B | §8.2; even VAF <10% counts as clinically relevant; below 5%, discuss with the lab | ERIC 2024: NGS preferred, no fixed VAF cut-off; S3: result ≤12 weeks old at treatment start | Done in Lund on a gene panel (section 6) |
| IGHV mutation status (once only) | B; optional earlier | §8.4.5: before treatment; may be done earlier to calculate IPS-E | EHA level II, grade B: before first-line treatment | Done in Lund |
| Bone marrow aspirate and biopsy | B in Sweden; C internationally | §8.2: before treatment; §7.1: for unexplained cytopenia | iwCLL: only for unclear cytopenia; EHA: "consider" for severe or unclear cytopenia | A real difference between guidelines |
| CT neck–chest–abdomen | B | §8.2 | iwCLL: "not generally indicated"; EHA: only if venetoclax is considered (TLS risk). The venetoclax SmPC requires imaging before starting | Not used for staging |
| HIV, hepatitis B and C serology | B | §8.2 | EHA, iwCLL; S3 adds hepatitis E. SmPCs require HBV screening before anti-CD20 drugs and HBV status before covalent BTKi | [I] Testing earlier helps plan hepatitis B vaccination (EHA recommends it during surveillance) |
| Haemolysis tests: reticulocytes, LD, haptoglobin, bilirubin, DAT | B; C at any time if anaemic | §8.2 | Onkopedia and NCCN: when haemolysis is suspected | — |
| Renal function; immune defect (neutrophils, hypogammaglobulinaemia); TLS bloods (Na, K, creatinine, phosphate, Ca, urate) | B | §8.2 | EHA Table 4 | Determines venetoclax logistics |
| ECG, cardiac history, blood pressure | B (if a BTKi is considered) | §12.1 | EHA: all patients when a BTKi is considered; ESC 2022: echocardiogram if high risk | — |
| β2-microglobulin | C | Removed (v8.0) | iwCLL "desirable"; S3 "sollte" (should) before therapy; part of CLL-IPI | Must be ordered specifically if a CLL-IPI score is wanted |
| PET-CT | C | §8.3, §17.2: only when transformation is suspected | iwCLL, EHA and S3 agree | — |
| Complex karyotype; NGS panels (NOTCH1, SF3B1 etc.) | C | §8.4.6: not routine | EHA: no testing outside trials; S3: karyotype "sollte" before each therapy | Guidelines disagree (below) |
| CMV serology | C | — | iwCLL: only for idelalisib, alemtuzumab or allogeneic transplant | — |
| BTK/PLCG2/BCL2 resistance mutations | C, at relapse only | §8.4.4.3, §15.1 | Onkopedia: may guide the next therapy | — |
| Germline or family testing | Not indicated | — | EHA: CLL is "familial, but not hereditary" | — |
Sources: VP8.2 ch. 7–8; iwCLL 2018; EHA 2026, Table 4; S3 v2.0; Onkopedia; Venclyxto SmPC; Gazyvaro SmPC.
Karyotyping: EHA and German S3 conflict. [E]
- EHA 2026 does not recommend testing for complex karyotype before treatment outside clinical trials (level III, grade B), citing limited reproducibility.
- The German S3 guideline says chromosome banding analysis "sollte" (should) be done before every treatment start or change.
- Onkopedia treats a complex karyotype as high risk.
- Sweden says it cannot yet be recommended in routine care.
[I] The disagreement is about how robust the evidence is, not about whether a highly complex karyotype carries a worse prognosis. A newly diagnosed patient does not need to resolve it now.
Imaging in SLL. No Swedish statement was found on baseline imaging when SLL is diagnosed from a node. EHA notes that SLL is staged with the imaging-based Lugano system. Whether a baseline CT is needed is therefore a fair question for the treating doctor.