3.1.2 Intermediate level

At the intermediate level (Level II), technologies requiring more sophisticated infrastructure, expertise or biosafety precautions are offered. An important aspect of laboratories at this level is the need for reliable and rapid sample transport networks from peripheral laboratories to the intermediate laboratory, and from the intermediate laboratory to the central laboratory. Combining an efficient specimen referral system with centralized testing can be a cost-effective approach where the burden is low or can be more sustainable where there are shortages of skilled staff to capacitate and maintain a large, quality-assured peripheral level network.

  • The new moderate complexity automated NAATs are suitable at this level. These tests require laboratory infrastructure that varies in size from just under 1 m wide (94 x 75.4 x 72.4 cm) to instruments over 4 m wide (429 x 216 x 129 cm). The class of technologies has varied throughput, from performing up to 24 samples (multi-disease) in one run to 96 samples (single disease) per run. Thus, depending on the specific product and setting, these tests could potentially be positioned at Level II or Level III.
  • Culture on liquid or solid media, or FL-LPA or SL-LPA (or both) using sputum specimens may also be applicable at this level, but such tests are gradually being superseded by more automated and rapid alternatives.


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