In recent years, there has been a significant surge in the use of molecular testing for diagnosing infectious diseases. This advancement brings with it an increased need for meticulous quality control (QC) measures to ensure the accuracy and reliability of test results. As primary point-of-care diagnostics (POCT) gain popularity, tests are often conducted by non-laboratory personnel, making QC indispensable in guaranteeing precise outcomes.
Laboratories are witnessing a transformation with the adoption of automated and commercially available tests. In this evolving landscape, QC emerges as a vital component for ensuring test compliance and meeting the performance standards set by manufacturers. Moreover, there is a growing emphasis on traceability and standardization of results, mandated by accreditation bodies. The implementation of robust QC protocols not only ensures result accuracy but also helps in curbing costs by minimizing repetitive and expensive testing due to errors.
However, navigating the realm of molecular testing poses its own set of challenges, primarily due to the multitude of in vitro diagnostic manufacturers and the wide array of available tests. This diversity underscores the critical importance of quality control in detecting potential errors early on. For instance, the market boasts over 200 commercial molecular tests designed for detecting human papillomavirus (HPV) alone. Moreover, the heterogeneous nature of equipment used for molecular diagnostics further complicates the standardization process.
Enter independent, third-party quality controls from external sources. These controls offer a reliable means to monitor the entire assay process, encompassing extraction, amplification, and detection. To ensure optimal performance, QC should be integrated at every stage of the assay process, including method validation, performance verification, and implementation.
The use of third-party QC products is indispensable across various scenarios:
1. External Process QC: Frequency defined by the laboratory.
2. Reagent Lot Change: Whenever a reagent lot is changed.
3. New Batch of Reagents: Upon the arrival of a new batch of reagents.
4. System Maintenance: Following system maintenance, partial replacement, or software updates.
5. Addressing Performance Issues: When performance issues need to be addressed.
6. Staff Training: Utilized as a staff training tool.
Hecin offers nucleic acid quality control products in the field of infectious disease testing. The product line covers hundreds of pathogens such as viruses, bacteria, or fungi. The products contain complete pathogens and can be used for performance validation of reagents for nucleic acid testing (e.g. PCR, LAMP, etc.) and laboratory quality control.
No. | Product Description |
1 | Acinetobacter baumannii |
2 | Adenovirus type 1 |
3 | Adenovirus type 11 |
4 | Adenovirus type 14 |
5 | Adenovirus type 2 |
6 | Adenovirus type 21 |
7 | Adenovirus type 3 |
8 | Adenovirus type 35 |
9 | Adenovirus type 4 |
10 | Adenovirus type 40 |
11 | Adenovirus type 41 |
12 | Adenovirus type 5 |
13 | Adenovirus type 55 |
14 | Adenovirus type 6 |
15 | Adenovirus type 7 |
16 | Aerococcus urinae |
17 | Aeromonas hydrophila |
18 | Arcanobacterium haemolyticum |
19 | Aspergillus flavus |
20 | Aspergillus fumigatus |
21 | Aspergillus niger |
22 | B.cereus |
23 | Bacillus cereus |
24 | Bacillus subtilis |
25 | Bacteroides fragilis |
26 | Boca virus |
27 | Bordetella bronchiseptica |
28 | Bordetella parapertussis |
29 | Bordetella pertussis (common) |
30 | Bordetella pertussis (drug-resistant type) |
31 | Botrytis cinerea bronchiseptica |
32 | Campylobacter coli |
33 | Campylobacter jejuni |
34 | Candida albicans |
35 | Candida crassa |
36 | Candida glabrata |
37 | Candida tropicalis |
38 | Canine distempervirus |
39 | Catamonas |
40 | Chlamydia pneumoniae |
41 | Chlamydia trachomatis |
42 | Chlamydophila pneumoniae |
43 | Citrobacter freundii |
44 | Clostridium difficile |
45 | Clostridium difficile toxin A |
46 | Clostridium difficile toxin B |
47 | Clostridium perfringens |
48 | Coronavirus 229E |
49 | Coronavirus MERS (pseudovirus) (N gene + ORFlab gene) |
50 | Coronavirus NL63 |
51 | Coronavirus OC43 |
52 | Coronavirus SARS (SARS) (pseudovirus) (Ngene)+ORFlab gene) |
53 | Coronavirus SARS-CoV-2 (new coronavirus) (pseudovirus) (N gene + ORFlab gene) |
54 | Coronavirus SARS-CoV-2 (new coronavirus) (pseudovirus) (N gene) |
55 | Coronavirus SARS-CoV-2 (new coronavirus) (pseudovirus) (ORFlab gene) |
56 | Corynebacterium diphtheriae |
57 | Corynebacterium ulcerans |
58 | Coxsackie virus type A24 |
59 | Coxsackievirus type A10 |
60 | Coxsackievirus type A12 |
61 | Coxsackievirus type A16 |
62 | Coxsackievirus type A5 |
63 | Coxsackievirus type A2 |
64 | Coxsackievirus type A4 |
65 | Coxsackievirus type A6 |
66 | Coxsackievirus type A7 |
67 | Coxsackievirus type A9 |
68 | Coxsackievirus type B1 |
69 | Coxsackievirus type B2 |
70 | Coxsackievirus type B3 |
71 | Coxsackievirus type B4 |
72 | Coxsackievirus type B5 |
73 | Coxsackievirus type B6 |
74 | Cryptococcus neoformans |
75 | Cytomegalovirus |
76 | Dengue virus type 1 |
77 | Dengue virus type 2 |
78 | Dengue virus type 3 |
79 | Dengue virus type 4 |
80 | E. coli (enteroaggregative) |
81 | E.coli O157 |
82 | EBV (human herpesvirus type 4) |
83 | Echovirus type 7 |
84 | Echovirus type 9 |
85 | Echovirus type 30 |
86 | Echovirus type 6 |
87 | Enterobacter aerogenes |
88 | Enterobacter sakazakii |
89 | Enterococcus faecalis |
90 | Enterococcus faecium |
91 | Enterovirus |
92 | Enterovirus EV70 |
93 | Enterovirus EV71 |
94 | Epstein-Barr Virus |
95 | Escherichia cloacae |
96 | Escherichia coli (common type) |
97 | Escherichia coli (entero-invasive) |
98 | Escherichia coli (enterotoxin-producing) |
99 | Escherichia coli (uropathogenic) |
100 | Escherichia coli bacteriophage MS2 |
101 | Escherichia coli EAEC |
102 | Escherichia coli EHEC |
103 | Escherichia coli EPEC |
104 | Escherichia coli ETEC |
105 | Escherichia coli STEC |
106 | Escherichia coli EIEC |
107 | Filobasidiella bacillispora |
108 | Gardnerella vaginalis |
109 | Group A Streptococcus |
110 | Group C Streptococcus |
111 | Haemophilus influenzae |
112 | Haemophilus influenzae Serotype A |
113 | Haemophilus influenzae Serotype B |
114 | Haemophilus influenzae Serotype C |
115 | Haemophilus influenzae Serotype D |
116 | Haemophilus influenzae Serotype E |
117 | Haemophilus influenzae Serotype F |
118 | Helicobacter pylori |
119 | Hemolytic streptococcus type B |
120 | Hepatitis A virus |
121 | Herpes Simplex Virus 1 |
122 | Herpes Simplex Virus 2 |
123 | HPV6 gDNA |
124 | HPV11 gDNA |
125 | HPV16 gDNA |
126 | HPV18 gDNA |
127 | HPV26 gDNA |
128 | HPV31 gDNA |
129 | HPV33 gDNA |
130 | HPV35 gDNA |
131 | HPV39 gDNA |
132 | HPV40 gDNA |
133 | HPV42 gDNA |
134 | HPV43 gDNA |
135 | HPV44 gDNA |
136 | HPV45 gDNA |
137 | HPV51 gDNA |
138 | HPV52 gDNA |
139 | HPV53 gDNA |
140 | HPV54 gDNA |
141 | HPV56 gDNA |
142 | HPV58 gDNA |
143 | HPV59 gDNA |
144 | HPV61 gDNA |
145 | HPV66 gDNA |
146 | HPV68 gDNA |
147 | HPV69 gDNA |
148 | HPV70 gDNA |
149 | HPV73 gDNA |
150 | HPV81 gDNA |
151 | HPV82 gDNA |
152 | HPV83 gDNA |
153 | Human cytomegalovirus (human herpesvirus 5) |
154 | Human herpes simplex virus type 1 |
155 | Human herpes simplex virus type 2 |
156 | Human parapneumovirus type A2 |
157 | Human parapneumovirus type B1 |
158 | Human parapneumovirus type B2 |
159 | Influenza A H1 |
160 | Influenza A H3 |
161 | Influenza A virus 2009 H1N1 |
162 | Influenza A virus H1N1 |
163 | Influenza A virus H3N2 |
164 | Influenza B |
165 | Influenza B virus Victoria |
166 | Influenza B virus Yamagata |
167 | Kingella kingae |
168 | Klebsiella oxytoc |
169 | Klebsiella pneumoniae |
170 | Klebsiella pneumoniae subsp. Ozaenae |
171 | Lacticaseibacillus paracasei |
172 | Lactobacillus casei |
173 | Lactobacillus curvatus |
174 | Legionella pneumophila |
175 | Legionella pneumophila subsp.pneumophila |
176 | Legionellapneumophila |
177 | Listeria monocytogenes |
178 | Measles virus |
179 | Metapneumovirus |
180 | Moraxella catarrhalis |
181 | Morganella morganii subsp. morganii |
182 | Mumps virus |
183 | Mycobacterium abscessus |
184 | Mycobacterium tuberculosis |
185 | Mycoplasma pneumoniae |
186 | Nearly smooth candida |
187 | Neisseria gonorrhoeae |
188 | Neisseria meningitidis (meningococcus) |
189 | Nocardia asteroides |
190 | Norovirus G1 |
191 | Norovirus G2 |
192 | Norovirus GII |
193 | P.aeruginosa |
194 | Parainfluenza virus type 1 |
195 | Parainfluenza virus type 2 |
196 | Parainfluenza virus type 3 |
197 | Parainfluenza virus type 4 |
198 | Parainfluenza virus type 1 |
199 | Parainfluenza virus type 2 |
200 | Parainfluenza virus type 3 |
201 | Parainfluenza virus type 4a |
202 | Parainfluenza virus type 4b |
203 | Parvimonas micra |
204 | Peptostreptococcus anaerobius |
205 | Phage M13 |
206 | Phage MS2 |
207 | Proteus mirabilis |
208 | Proteus vulgaris |
209 | Proteus vulgaris |
210 | Proteus vulgaris Hauser |
211 | Providencia stuartii |
212 | Pseudomonas aeruginosa |
213 | Respiratory syncytial virus type A |
214 | Respiratory syncytial virus type B |
215 | Respiratory syncytial virus type A |
216 | Respiratory syncytial virus type B |
217 | Rhinovirus |
218 | Rhinovirus type A2 |
219 | Rhinovirus type A21 |
220 | Rhinovirus type A30 |
221 | Rhinovirus type A31 |
222 | Rhinovirus type A54 |
223 | Rhinovirus type A58 |
224 | Rhinovirus type A63 |
225 | Rhinovirus type A78 |
226 | Rhinovirus type A81 |
227 | Rhinovirus type A89 |
228 | Rhinovirus type B52 |
229 | Rhinovirus type B70 |
230 | Rhinovirus type B72 |
231 | Rhodococcus mucosus |
232 | Rubella virus |
233 | Salmonella enterica |
234 | Salmonella enteritidis |
235 | Salmonella paratyphi-A |
236 | Salmonella paratyphi-B |
237 | Serratia marcescens |
238 | Shigella |
239 | Shigella flexneri |
240 | Shigella fowleri (common) |
241 | Shigella fowleri (invasive) |
242 | Staphylococcus aureus (common) |
243 | Staphylococcus aureus (MRSA) |
244 | Staphylococcus epidermidis |
245 | Staphylococcus saprophyticus |
246 | Stenotrophomonas maltophilia |
247 | Streptococcus mutans |
248 | Streptococcus agalactiae |
249 | Streptococcus canis |
250 | Streptococcus dysgalactiae |
251 | Salmonella enterica subsp. enterica |
252 | Streptococcus mitis |
253 | Streptococcus oralis |
254 | Streptococcus pneumoniae |
255 | Streptococcus pyogenes |
256 | Syphilis spirochetes |
257 | Trichomonas vaginalis |
258 | Ureaplasma urealyticum |
259 | Varicella-Zoster Virus |
260 | Vibrio campbellii |
261 | Vibrio cholerae |
262 | Vibrio parahaemolyticus |
263 | Vibrio vulnificus |
264 | Yersinia enterocolitica |
265 | Yersinia enterocolitica small intestine |
266 | Zika virus |
267 | β-Hemolytic streptococcus |
268 | Salmonella enterica subsp. enterica serovar Typhi |
269 | Salmonella enterica subsp. enterica serovar Typhimurium |
270 | Streptococcus agalactiae (Group B Streptococcus) |
271 | Streptococcus dysgalactiae subsp. equisimilis |
272 | Streptococcus equi subsp. zooepidemicus |
273 | Streptococcus pneumoniae Serotype 14 |
274 | Streptococcus pyogenes (Group A Streptococcus) |
275 | Streptococcus salivarius (Streptococcus oxysporus) |
276 | Varicella-Zoster Virus (human herpesvirus type 3) |
