Stability of Lyophilized Human Serum for Use as Quality Control Material in Bhutan

Abstract

Quality control (QC) materials are crucial for internal quality control (IQC) and external quality assessment scheme (EQAS). However, many developing countries are disadvantaged by unavailability and high cost of commercial control material. Therefore, preparing homemade lyophilized human serum will be cost effective for used as a QC material in Bhutan. We prepared lyophilized QC material using serum collected from Bhutanese volunteers. The stability of lyophilized serum was studied at 3 selected conditions by analyzing at certain intervals. The results were statistically compared with initial values. The significant p values (\0.05) were seen in glucose, BUN, ALT, total bilirubin and protein at 2-8°C but no significant difference were observed at -20°C at the end of 9 months. We concluded that, home-made lyophilized human serum prepared without stabilizers could be used at least up to 9 months if stored at -20°C and 7 months at 2-8°C. Stabilizers and additives are necessary if the materials are to be used longer than 7-9 months.

Efficacy of Pooled Serum Internal Quality Control in Comparison with Commercial Internal Quality Control in Clinical Biochemistry Laboratory

“…Lalani et al 7 in their study showed that homemade QC from polycythemia patient is better than commercial QC. Jamtsho 8 in his study proposed that stability of lyophilized QC is better than commercial QC. Bowes et al 9 in their study showed that pooled serum QC is more stable and low-cost when compared with commercial QC.…”

Increasing Trend of Clinical Laboratory Testing at Gelephu Central Regional Referral Hospital, Bhutan

“…[13,15] The TB laboratory participates in EQA programme conducted by Royal Centre for Disease control (RCDC); such as blinded rechecking and competency panel testing. [16,18] The Hematology analysis at CRRH is done using Sysmex XS-1000i, a fully automated analyzer under the RRS scheme introduced in 2015. Earlier hematology tests, such as total WBC count, platelet count and WBC differential count were performed manually.…”

“…The hematology unit performs in-house IQC with Delta check method and does not participate in any EQA programme. [18] Routine urine examination, urine acetone, pregnancy test, stool occult blood test and stool microscopy for parasite is conducted at parasitology unit following SOP. [19] During emergencies rapid test kits are used to perform urine analysis.…”