STD: Inhibition - Serum Quantitative Rule (PICQUANT_SERUM)

Version: v1.0.2 Status: Draft SRS Source: docusaurus/docs/srs/rules/rule-inhibition-serum-quantitative.md Rule Name: PICQUANT_SERUM Domain: RULES-INHSERUMQUANT

---

Overview

This document specifies tests for the Inhibition - Serum Quantitative rule using decision tables and test vectors. The rule evaluates Internal Control (IC) inhibition for serum quantitative samples by assessing IC CT values against thresholds and evaluating non-IC observation quantification levels.

Rule Characteristics:

• Pure business logic (no UI)
• Specimen type filtering (Serum only)
• Three-threshold decision tree (IC CT, LoD, high quantification)
• Boundary-sensitive (inclusive vs. exclusive thresholds)

Test Method: TM-API (per Test Plan section 3.3 - Rules use automated API tests)

Verification Approach: Rule verification is performed using data-driven test vectors. Each row in a decision table represents a complete verification scenario with defined inputs and expected outputs. This format enables exhaustive condition coverage while remaining concise and auditable.

---

Coverage Summary

REQ ID	Title	Conditions	Test Vectors	Coverage	Gaps
REQ-RULES-INHSERUMQUANT-001	Evaluate IC Inhibition for Serum Quantitative Samples	18	21	100%	None

Totals: 1 REQ, 18 Conditions, 21 Test Vectors, 100% Coverage

---

REQ-RULES-INHSERUMQUANT-001: Evaluate IC Inhibition for Serum Quantitative Samples

Input Variables

Variable	Type	Valid Values	Description
specimen_type	string	Serum, Plasma, Urine, ...	Sample specimen type
ic_ct	float	null, numeric	Internal Control CT value
ic_present	bool	true, false	Whether IC observation exists in well
non_ic_obs	array	[], [{qty: N}, ...]	Non-IC observations with quantities
lod	float	null, numeric	Limit of Detection threshold (per mix/target)

Output Variables

Variable	Type	Description
result	string	Pass, Error, Skip
error_code	string?	Error code if result is Error (null otherwise)

Constants

Constant	Value	Description
IC_CT_THRESHOLD	35	CT value threshold (inclusive: <= passes)
HIGH_QUANT_THRESHOLD	10,000	Quantity threshold for elevated IC compensation (inclusive: >= required)

---

Decision Table: Specimen Type Filtering

TV	specimen_type	ic_ct	non_ic_qty	result	Covers
TV-001-001	Serum	30	500	Pass	AC: Serum specimen triggers rule
TV-001-002	Plasma	38	500	Skip	AC: Non-serum skips rule
TV-001-003	Urine	38	500	Skip	AC: Non-serum skips rule

---

Decision Table: Normal IC CT Path (IC CT <= 35)

TV	specimen_type	ic_ct	non_ic_qty	result	Covers
TV-001-004	Serum	30	500	Pass	AC: IC CT well below threshold
TV-001-005	Serum	34.9	500	Pass	AC: IC CT just below threshold
TV-001-006	Serum	35	500	Pass	AC: Boundary - IC CT exactly at threshold (inclusive)

---

Decision Table: Elevated IC CT Decision Path

TV	specimen_type	ic_ct	qty_above_lod	qty_above_10k	result	Covers
TV-001-007	Serum	36	false	false	Error	AC: Elevated IC, no qty > LoD
TV-001-008	Serum	36	true	false	Error	AC: Elevated IC, qty > LoD but < 10,000
TV-001-009	Serum	36	true	true	Pass	AC: Elevated IC, high quantification compensates
TV-001-010	Serum	40	false	false	Error	AC: High IC CT, insufficient detection
TV-001-011	Serum	38	true	true	Pass	AC: Elevated IC, high quantification

---

Decision Table: Quantification Boundary Conditions

TV	specimen_type	ic_ct	non_ic_qty	lod	qty_vs_lod	qty_vs_10k	result	Covers
TV-001-012	Serum	36	10,000	100	above	at	Pass	AC: Boundary - qty exactly 10,000 (>= 10,000, passes)
TV-001-013	Serum	36	10,001	100	above	above	Pass	AC: Qty just above 10,000 threshold
TV-001-014	Serum	36	5,000	100	above	below	Error	AC: Moderate qty insufficient
TV-001-015	Serum	36	100	100	at	below	Error	AC: Qty at LoD, not above
TV-001-016	Serum	36	101	100	above	below	Error	AC: Qty just above LoD, still insufficient

---

Decision Table: Error Handling / Edge Cases

TV	specimen_type	ic_present	ic_ct	non_ic_obs	lod	result	Covers
TV-001-017	Serum	false	N/A	[{qty: 500}]	100	Skip	AC: No IC observation in well
TV-001-018	Serum	true	null	[{qty: 500}]	100	Skip	AC: IC CT value is null
TV-001-019	Serum	true	38	[]	100	Skip	AC: No non-IC observations
TV-001-020	Serum	true	38	[{qty: 500}]	null	Pass*	AC: LoD unavailable, use default
TV-001-021	Serum	true	invalid	[{qty: 500}]	100	Skip	AC: IC CT value is invalid

*Note: TV-001-020 uses default LoD when configuration unavailable; actual result depends on default LoD value vs. quantity.

---

Full Path Coverage Matrix

TV	specimen_type	ic_ct	ic_ct_cond	qty_vs_lod	qty_vs_10k	result	Path
TV-001-002	Non-Serum	Any	N/A	N/A	N/A	Skip	P1: Not applicable
TV-001-006	Serum	35	<= 35	N/A	N/A	Pass	P2: Normal IC
TV-001-007	Serum	36	> 35	false	N/A	Error	P3: Insufficient detection
TV-001-008	Serum	36	> 35	true	false	Error	P4: Moderate qty insufficient
TV-001-009	Serum	36	> 35	true	true	Pass	P5: High qty compensates

---

Automation Status

REQ ID	Test Vectors	Automation Status	Notes
REQ-RULES-INHSERUMQUANT-001	TV-001-001 to TV-001-021	Automated	Data-driven parameterized tests

---

Traceability to Existing Tests

Requirement	Jira Tests	Status
REQ-RULES-INHSERUMQUANT-001	BT-5194, BT-5665	Partial

---

Gap Analysis

Identified Gaps

Gap	Requirement	Description	Priority	Owner
GAP-001	REQ-RULES-INHSERUMQUANT-001	BT-5194/BT-5665 cover 6 TVs; remaining TVs need coverage	Medium	TBD

Remediation Plan

1. GAP-001: Extend BT-5194/BT-5665 fixtures to cover remaining TVs (serum-specific boundary conditions)

---

Test Data Requirements

Specimen Type Test Data

ID	Description	specimen_type
TD-SPEC-001	Serum specimen	Serum
TD-SPEC-002	Plasma specimen	Plasma
TD-SPEC-003	Urine specimen	Urine

IC CT Test Values

ID	Description	ic_ct
TD-CT-001	Normal range	30
TD-CT-002	Just below threshold	34.9
TD-CT-003	At threshold (boundary)	35
TD-CT-004	Just above threshold	35.1
TD-CT-005	Moderately elevated	38
TD-CT-006	Highly elevated	40
TD-CT-007	Null value	null

Quantification Test Values

ID	Description	qty	lod	qty_vs_lod	qty_vs_10k
TD-QTY-001	Below LoD	50	100	below	below
TD-QTY-002	At LoD	100	100	at	below
TD-QTY-003	Above LoD, below high	5,000	100	above	below
TD-QTY-004	At high threshold	10,000	100	above	at
TD-QTY-005	Just above high	10,001	100	above	above
TD-QTY-006	Well above high	15,000	100	above	above